McIntyre Law's FDA Recall Watch

FDA Recall Watch

Published on March 17, 2020

The U.S. Food and Drug Administration (FDA) is the federal government agency responsible for regulating not only food and drugs but also biologics (things like vaccines, blood, and tissue), medical devices (like breast implants or knee replacements), and even tobacco, cosmetics, microwave ovens, and pet food. The FDA is charged with protecting public safety and health when it comes to these products. When necessary as part of its duties, the agency must occasionally make sure that some of these unsafe products are removed from public circulation through its recall process.

Understanding FDA Recalls of Drugs and Medical Devices

An FDA recall of a drug or medical device is the often voluntary action of a company to correct and/or remove a medicine or product from public circulation because it’s in violation of the laws and regulations that the FDA is charged with enforcing. The nature of the violation may or may not be dangerous. But sometimes they’re deadly. Recalls are an important tool that the government uses to protect the public.

How the FDA Determines Recalls

A defective drug or medical device can be placed on the FDA recall list simply for being in violation of the law or regulations, even if it isn’t known to be dangerous. Although most recalls are voluntary, the FDA is responsible for overseeing how the drug or medical device recall is conducted, assessing the scope of the problem, making sure the violator’s actions are adequate, and classifying the recall according to seriousness. For instance, when evaluating a company’s medical device recall strategy, the FDA considers several factors, including (but not limited to):

  1. Results of a health hazard evaluation assessing the extent of any harm done, to whom, for how long.
  2. How well the product being recalled can be identified.
  3. How obvious it is to the general public that the recalled product is deficient.
  4. How much the product is used or unused in the market.
  5. Making sure essential products remain available.

What’s the difference between Class I, II, and III recalls?

How the FDA Classifies Recalls

FDA recalls fall into one of three medical device and drug recall classes, which reflect the danger posed to the public by the product that’s in violation.

  • Class I recall: This is the most serious of the medical device and drug recall classes. This category is for dangerous or defective products that could reasonably be expected to cause serious adverse health problems or even death.
  • Class II recall: Products in this category might cause temporary or medically reversible health problems, but the likelihood of severe danger is remote.
  • Class III recall: It’s unlikely that products in this category will cause any adverse health problems. They are simply in violation of a law or regulation enforced by the FDA.

Have you suffered after using a drug or medical device on the FDA recall list? Call McIntyre Law to start your case today! (877) 917-5250

Recent FDA Recalls

Not all FDA recalls are given press releases or are posted on the FDA recall list on the agency’s website. However, important information is posted regularly. McIntyre Law believes this to be a vital service to the public. Knowing what medication is recalled or which medical devices are defective can prevent further harm to patients. Here, we list some of the most important recent FDA recalls that the public should know about.

September 2021 FDA Recalls

  • All Eco-Med ultrasound gels and lotions have been recalled by Eco-Med Pharmaceutical, Inc. due to the risk of bacterial contamination.
  • LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests have been recalled by Magellan Diagnostics, Inc. due to a risk of false or inaccurate results.
  • One lot of Glucagon Emergency Kits have been recalled by Eli Lilly and Company due to a potentially dangerous loss of potency.
  • AMSORB PLUS PREFILLED G-CAN 1.0L canisters have been recalled by Armstrong Medical Limited due to the risk of reduced airflow to patients.
  • Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands has been recalled by Cordis Corporation because the marker bands may move or dislodge during use.
  • Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology have been recalled by Medtronic due to the risk of fractures or breaks in the device’s delivery system.
  • Cefazolin Injection Products have been recalled by IntegraDose Compounding Services, LLC due to concerns about the drug’s sterility.
  • NORMOFLO® Irrigation Fluid Warmer and Warmers Sets have been recalled by Smiths Medical ASD, Inc. due to the risk of unsafe exposure to aluminum.
  • Level 1® Fast Flow Fluid Warming System, NORMOFLO® Fluid Warmer, and Level 1® Normothermic I.V. Fluid Administration Set have been recalled by Smiths Medical ASD, Inc. due to the potential exposure to toxic levels of aluminum.
  • Recirculator 8.0 Disposable Lavage Kit has been recalled by Eight Medical International due to an increased risk of exposure to high levels of aluminum.
  • Ruzurgi® (amifampridine) 10 mg tablets have been recalled by Jacobus Pharmaceutical Company Inc. after the discovery of yeast, mold, and bacterial contamination.
  • Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines have been recalled by Philips Respironics due to potential health risks upon use.
  • Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit has been recalled by Azurity Pharmaceuticals, Inc. after the kits were found to contain the wrong diluent.
  • Aminosyn II 15%, an amino acid injection, Sulfite Free IV Solution has been recalled by ICU Medical, Inc. due to the presence of fibers, hair, and other particulate matter.
  • Lidocaine HCl Topical Solution 4%, 50ml, has been recalled by Teligent Pharma, Inc. due to super potency.
  • LeadCare® Test Kits have been recalled by Meridian Bioscience, Inc. due to a risk of inaccurate readings.

August 2021 FDA Recalls

  • Spectrum IQ Infusion Pumps have been issued an Urgent Medical Device Correction by Baxter International Inc. due to potential network connectivity errors.
  • Alaris Infusion Pump Module Model 8100 has been recalled by Bio-Medical Equipment Service Co. due to deficiencies in the device’s bezel.
  • Monoject™ Flush Prefilled Saline Syringes have been recalled by Cardinal Health due to the risk of air embolisms and other adverse health effects during use.
  • Argyle UVC Insertion Tray has been recalled by Cardinal Health due to missing instructions for use.
  • Four lots of CHANTIX® (Varenicline) 0.5mg/1 mg Tablets have been recalled by Pfizer due to the presence of N-nitroso-varenicline, a potentially harmful nitrosamine.
  • Dose IQ Software Version 9.0.x has been recalled by Baxter Healthcare because of software defects.
  • HeartWare Ventricular Assist Device (HVAD) System has been recalled by Medtronic due to an increased risk of adverse events that may result in injury or death.
  • INGENIO family of pacemakers and CRT-Ps have been recalled by Boston Scientific due to operational defects that may cause the devices to enter safety mode.
  • Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL has been recalled by SterRx, LLC after a microbial contamination was detected.
  • Atovaquone Oral Suspension, USP 750 mg/5mL, has been recalled by KVK Tech, Inc. due to defects resulting from exposure to extreme temperatures during shipping.
  • Eco-Gel 200 ultrasound gel has been recalled by Eco-Med Pharmaceutical, Inc. due to bacterial contamination.
  • V60 and V60 Plus ventilators have been recalled by Philips Respironics due to the risk of reduced oxygen flow to users.

July 2021 FDA Recalls

  • GENOSYL DS; Nitric Oxide Delivery System has been recalled by Vero Biotech due to software error.
  • Twelve Lots of CHANTIX® (Varenicline) Tablets have been recalled by Pfizer due to N-Nitroso Varenicline content above ADI level.
  • NEUTROGENA® and AVEENO® Aerosol Sunscreen Products have been recalled by Johnson & Johnson Consumer Inc. due to the presence of benzene.
  • Injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg have been recalled by Innoveix Pharmaceuticals, Inc. due to a lack of sterility assurance.
  • LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests have been recalled by Magellan Diagnostics, Inc. due to risk of falsely low results.
  • Lyra SARS-CoV-2 Assay (M120) has been recalled by Quidel due to risk of false negative results.
  • Angiographic Guidewire Component has been recalled by Medtronic Vascular due to being nonsterile.
  • One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) has been recalled by Teva Pharmaceuticals due to the presence of particulate matter.
  • Limar Hand Sanitizer Packaged in 4 oz Bottles has been recalled by Ardil Commercial due to being packaged in bottles that resemble drink containers.

June 2021 FDA Recalls

  • Medical Convenience Kits have been recalled by Avid Medical due to risk of fungal contamination.
  • Surgical Procedure Packs have been recalled by DeRoyal Industries due to mislabeled lidocaine.
  • Prairie Wolf Distillery Hand Sanitizer Packed in 16.9 Oz. and 20 Oz Bottles has been recalled by Prairie Wolf Spirits, Inc. due to resembling drink containers.
  • Durisan Non Alcohol Antimicrobial Hand Sanitizer products have been recalled by Sanit Technologies LLC d/b/a Durisan due to microbial contamination.
  • Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes have been recalled by Smiths Medical due to skewed odd-number line graduation markings on syringe barrels.
  • Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices have been recalled by Philips due to potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
  • Metformin HCl Extended-Release Tablets, USP 750 mg, have been recalled by Viona Pharmaceuticals Inc. due to the detection of N-Nitrosodimethylamine (NDMA) impurity.
  • Innova SARS-CoV-2 Antigen Rapid Qualitative Test has been recalled by Innova Medical Group due to the risk of false test results.
  • FiberCel Fiber Viable Bone Matrix (“FiberCel”), Donor Lot Number NMDS210011, has been recalled by Aziyo Biologics, Inc. due to possible post-surgical infection.
  • Alaris Infusion Pump Module 8100 Bezel has been recalled by the Biomed Guys due to possible cracked or separated bezel repair posts.

May 2021 FDA Recalls

  • SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) have been recalled by Lepu Medical Technology due to risk of false results.
  • Alaris Infusion Pump Module 8100 Bezel >has been recalled by Step-Har Medical due to possible separated bezel repair posts.
  • Medical Convenience Kits have been recalled by Medical Action Industries, Inc. 306 due to risk of fungal contamination.
  • VICI VENOUS STENT System and VICI RDS VENOUS STENT System have been recalled by Boston Scientific Corporation due to possible stent migration.
  • Durisan Non Alcohol Antimicrobial Hand Sanitizer has been recalled by Sanit Technologies LLC d/b/a Durisan due to bacterial contamination.
  • Assurity™ and Endurity™ Pacemakers have been recalled by Abbott (formally known as “St. Jude Medical”) due to the risk of electrical shortages.
  • Medically Minded Hand Sanitizer has been recalled by Global Sanitizers due to methanol contamination.
  • HeartWare HVAD System Instructions for Use and Patient Manual have been recalled by Medtronic to update safety information.
  • Goose Creek Hand Sanitizer and COCO TKO Hand Sanitizer have been recalled by Scentsational Soaps & Candles, Inc. due to the presence of wood alcohol and other contaminants.
  • DIBAR Labs Hand Sanitizer has been recalled by Dibar Nutricional S. de R.L. De C.V. due to the presence of wood alcohol, or methanol.
  • Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® product samples have been recalled by Novo Nordisk due to improper storage temperature conditions.
  • 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and 1% Lidocaine HCl Injection, USP 30 mL, have been recalled by Hospira, Inc. due to product mislabeling.
  • Sterile Water for Injection, USP, 100 mL, has been recalled by Hospira, Inc. due to the potential presence of particulate matter.

April 2021 FDA Recalls

  • NP Thyroid®, Thyroid Tablets, USP, have been recalled by Acella Pharmaceuticals, LLC due to subpotency.
  • Scented Hand Sanitizers have been recalled by Scentsational Soaps & Candles, Inc. due to the undeclared presence of methanol and other contaminants.
  • Precise PRO Rx US Carotid System has been recalled by Cordis Corporation due to a risk of separation during use.
  • ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator has been recalled by Becton, Dickinson and Company (BD) after a manufacturing error caused defects.
  • Bio-Console 560 Extracorporeal Blood Pumping Console has been recalled by Medtronic due to the possibility of electrical failure during use.
  • Alaris Pump Bezel Assembly and Alaris Infusion Pumps have been recalled by Tenacore LLC due to possible cracks in bezel repair posts.
  • 2001 Tenacore Replacement CareFusion Alaris 8100 bezels have been recalled by Tenacore LLC due to weakened plastic that can disrupt infusion.
  • BD Alaris Pump Module has been recalled by CareFusion 303, Inc. due to issues with stuck and unresponsive keys.
  • HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports have been recalled by Medtronic due to the risk of damaged connector plugs and controller ports.
  • Durisan Antimicrobial Hand Sanitizer has been recalled by Sanit Technologies, LLC d/b/a Durisan due to a microbial contamination.
  • Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) have been recalled by Medtronic due to decreased battery life.
  • ThermaCor 1200 Rapid Thermal Infusion System disposable sets have been recalled by Smisson-Cartledge Biomedical, LLC due to potential aluminum leaks.
  • Valiant Navion Thoracic Stent Graft System has been recalled by Medtronic due to the risk of fracturing or leaking during use.
  • Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles, have been recalled by A-S Medication Solutions, LLC due to having incomplete drug labels.

March 2021 FDA Recalls

  • HVAD Pump Implant Kits have been recalled by Medtronic due to delayed or failed restart after the pump is stopped.
  • Spironolactone tablets, 25 mg and 50 mg, have been recalled by Bryant Ranch Prepack due to mislabeling with the incorrect strength.
  • Phenylephrine Hydrochloride Injection, USP, 10 mg/mL, has been recalled by Sagent Pharmaceuticals, Inc. due to a lack of sterility assurance.
  • Heal the World Hand Sanitizer, in 9.6 oz. bottles, has been recalled by PNHC, LLC d/b/a Heal the World due to risk of ingestion because they resemble water bottles.
  • Kodama Intravascular Ultrasound Catheters have been recalled by Acist due to the risk of broken O-ring pieces flushing into arteries during use.
  • Valkyrie LTOWB Collection and Administration, Low Titer Type O FWB Transfusion Sets and Low Titer Type O Donor Collection Sets, Fresh Whole Blood Transfusion Sets and Fresh Whole Blood Donor Sets have been recalled by Combat Medical Systems, LLC due to possible bent or broken needles.
  • Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface have been recalled by Medtronic due to possible high levels of endotoxins.
  • Durisan Antimicrobial Hand Sanitizer has been recalled by Sanit Technologies LLC d/b/a Durisan due to microbial contamination.
  • ChloraPrep 3 mL Applicators have been recalled in every state now by Becton Dickinson and Company due to potential Aspergillus penicillioides contamination.
  • Telmisartan Tablets, USP, 20 mg have been recalled by Alembic Pharmaceuticals, Inc. due to the incorrect product strength on labels.
  • Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, has been recalled by Zydus Pharmaceuticals Inc. due to crystallization.
  • Guanfacine Extended-Release Tablets 2mg have been recalled by Apotex Corp. due to trace amounts of Quetiapine Fumarate.

February 2021 FDA Recalls

  • Unused Valiant Navion Thoracic Stent Graft System has been recalled by Medtronic due to endoleaks, stent fractures, and stent ring enlargement.
  • Liko Multirall 200 Overhead Lift has been recalled by Hillrom due to failure to properly attach the Q-link strap lock (also known as the Q-link 1 strap lock) to the S65 hook.
  • EMBLEM S-ICD Subcutaneous (Subcutaneous Implantable Cardioverter Defibrillator) System (Models S-ICD A209 and MRI S-ICD A219) has been recalled by Boston Scientific due to risk of short-circuit.
  • Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules have been recalled by Adamssecret.co due to the presence of undeclared sildenafil and/or tadalafil.
  • EMBLEM S-ICD Subcutaneous Electrodes (Model 3501) have been recalled by Boston Scientific due to risk of fractures.
  • Medfusion 3500 and 4000 Syringe Pumps have been recalled by Smiths Medical due to a risk of medication delivery error.
  • ManukaGuard Allercleanse Nasal Spray has been recalled by NDAL MFG INC due to contamination with yeast.
  • Enoxaparin Sodium Injection, USP, batches have been recalled by Apotex Corp. due to mislabeling of syringe barrel measurement markings.

January 2021 FDA Recalls

  • Deluxe Heat Therapy Massagers, Model 4212, have been recalled by Wahl Clipper Corporation due to risks of overheating.
  • Cisatracurium Besylate Injection, USP 10mg per 5mL, has been recalled by Meitheal Pharmaceuticals, Inc. because of a labeling error.
  • LOTUS Edge™ Aortic Valve System has been recalled by Boston Scientific Corporation due to issues with the product’s delivery system.
  • Ketorolac Tromethamine Injection, USP 30 mg/mL, has been recalled by Fresenius Kabi USA due to the presence of potentially harmful particulate matter.
  • Soho Fresh 70% Rubbing Alcohol has been recalled by Essaar Inc. due to methanol contamination.
  • Metformin HCl Extended Release Tablets, USP 750 mg, have been recalled by Nostrum Laboratories, Inc. due to unsafe levels of N-Nitrosodimethylamine (NDMA).

December 2020 FDA Recalls

  • Chlorhexidine Gluconate Oral Rinse, USP 0.12%, 15mL, has been recalled by Precision Dose, Inc. due to the possible presence of bacteria.
  • Paroex® Chlorhexidine Gluconate Oral Rinse, USP 0.12%, has been recalled by Sunstar Americas, Inc. due to a potential bacterial contamination.
  • Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers have been recalled by Cook Medical because of an increased chance of separation during use.
  • IMC Wash-Free Hand Sanitizer has been recalled by Shane Erickson, Inc. DBA Innovative Marketing Consultants due to a potential methanol contamination.
  • JET 7 Catheters with Xtra Flex Technology have been recalled by Penumbra due to an increased risk of unexpected death and serious injury.
  • Sildenafil 100 mg tablets and Trazodone 100mg tablets have been recalled by AvKare due to a product mix-up that occurred during bottling.
  • Anagrelide Capsules, USP 1mg, have been recalled by Torrent Pharmaceuticals Limited due to dissolution test failure.
  • Sigma Spectrum Infusion Pumps (V6, V8, and V9) have been recalled by Baxter Healthcare due to issues with unplanned shutdowns during use.
  • Regenecare HA Topical Anesthetic Hydrogel has been recalled by MPM Medical, LLC due to a confirmed bacterial contamination.

November 2020 FDA Recalls

  • Cook Medical Fixed Core Wire Guide has been recalled by Cook Medical because of a manufacturing error that damaged the device.
  • Dexmedetomidine HCL in 0.9% Sodium Chloride Injection has been recalled by Fresenius Kabi USA due to the presence of small amounts of lidocaine.
  • Trevo XP ProVue Retriever has been recalled by Stryker Neurovascular due to faulty wires that may break or separate during use.
  • Chlorhexidine Gluconate Oral Rinse, USP 0.12%, has been recalled by Lohxa, LLC due to a possible microbial contamination.
  • Rashkind Balloon Septostomy Catheters have been recalled by Medtronic Inc. due to quality issues that may cause the device to seperate or fail during use.
  • Metformin HCl Extended Release Tablets, USP 500 mg and 750 mg, have been recalled by Nostrum Laboratories due to unsafe N-Nitrosodimethylamine (NDMA) levels.

October 2020 FDA Recalls

  • Sigma Spectrum Infusion Pumps (V6, V8 and IQ) have been issued an Urgent Device Correction by Baxter International Inc. after deviations from the specified cleaning methods led to serious injuries.
  • Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, has been recalled by Sunstar Americas, Inc. (SAI) because of a potential bacterial contamination.
  • Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, have been recalled by Marksans Pharma Limited due to unsafe levels of N-nitrosodimethylamine (NDMA).
  • Smart Care Hand Sanitizer, 0.84 oz. pouches, has been recalled by Ashtel Studios due to packaging that resembles a food or drink container.
  • Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits have been recalled by Becton, Dickinson and Company (BD)/CareFusion 303, Inc. due to stuck or unresponsive keys, which can lead to infusion problems.

September 2020 FDA Recalls

  • Cleaner Hand Sanitizer, 500 mL and 1,200 mL, has been recalled by Estado de México, México, DMM VISSION, S.A. de C.V due to the possible presence of methanol.
  • Riomet ER, 500 mg per 5 mL, has been recalled by Sun Pharmaceutical Industries because of an N-Nitrosodimethylamine (NDMA) impurity.
  • NP Thyroid 15 & NP Thyroid 120 Tablets have been recalled by Acella Pharmaceuticals, LLC due to sub-potent amounts of levothyroxine (T4).
  • Alaris™ Syringe and Alaris™ PCA Modules have been recalled by Becton, Dickinson and Company (BD) because of possible display errors that can result in over- or under-infusion.
  • Alaris™ System Infusion Pumps have been recalled by Becton, Dickinson and Company (BD) due to four potential hardware malfunctions.
  • Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits have been recalled by Becton, Dickinson and Company (BD) due to keys that may become unresponsive or stuck.
  • All lots of M Hand Sanitizer Alcohol Antiseptic 80%, 128 oz/3,785 mL, have been recalled by Medek, LLC due to potential methanol presence and sub-potent ethanol levels.
  • bio aaa Advance Hand Sanitizer (lot 20DF8307) has been recalled by AJR Trading LLC because of possible methanol contamination.
  • Nature-Throid® and WP Thyroid® have been recalled by RLC Labs, Inc. due to sub-potent levels of Liothyronine (T3) and Levothyroxine (T4).
  • All lots of Leafree Instant Hand Sanitizer Aloe Vera have been recalled by CorgioMed, LLC because products are labelled as “edible alcohol.”

August 2020 FDA Recalls

  • All lots of Always Be Clean Hand Sanitizer and Just Hand Sanitzer that have been labeled to contain methanol have been recalled by Open Book Extracts for being mislabeled.
  • Mylan Tranexamic Acid and Amiodarone HCl Injections have been recalled by Mylan N.V. because of vials potentially packaged in incorrect cartons.
  • Harmonic Nature Hand Sanitizer has been recalled by Harmonic Nature S. de R.L. Mi due to the potential presence of 1-propanol.
  • Zanilast+ Hand Sanitizer Gel has been recalled by Nanomateriales, S.A. de C.V. due to the undeclared presence of 1-propanol.
  • V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel, and Protz Real Protection Antibacterial Hand Sanitizer have been recalled by Asiaticon S.A. de C.V. due to the possible presence of methanol and sub-potent ethanol levels.
  • Medfusion 3500 and 4000 Syringe Pumps have been recalled by Smiths Medical due to a software error that may cause an over- or under-delivery of medications.
  • Florence Morris Antiseptic Hand Sanitizer has been recalled by Grupo Asimex de Mexico S.A. de C.V. due to possible methanol contamination and sub-potent ethanol content.
  • Metformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750 mg, have been recalled by Bayshore Pharmaceuticals, LLC due to unsafe levels of the impurity N-Nitrosodimethylamine (NDMA).
  • Nuuxsan, Modesa, Assured & Next Hand Sanitizers have been recalled by ALBEK de Mexico S.A. de C.V. due to the undeclared presence of methanol, or wood alcohol.
  • Goldenseal Root Powder has been recalled by Maison Terre due to microbial contamination.
  • Yacana Hand Sanitizer, 70% alcohol content, has been recalled by Grupo Yacana México S.A.S de C.V. due to potential methanol contamination and sub-potent ethanol content.
  • Heparin Sodium Compounded products have been recalled by SCA Pharmaceuticals due to the presence of the undeclared preservative benzyl alcohol.
  • SkinGuard24 Hand Sanitizer has been recalled by SG24 LLC due to an indication of methanol presence on the label.
  • ChloraPrep™ 3 mL applicators have been recalled by Becton, Dickinson and Company (BD) due to a potential fungal contamination.
  • Bersih Hand Sanitizer Gel (fragrance-free) has been recalled by Soluciones Cosmeticas due to the potential presence of methanol.
  • Gelbac T Antibacterial Hand Gel has been recalled by Incredible Products S.A. de C.V. due to possible methanol contamination.
  • BodyGuard Infusion Pump Systems have had their April 2020 recall updated by CME America due to medication infusion errors.
  • DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL have been recalled by Ferring Pharmaceuticals US due to higher-than-specified amounts of desmopressin.
  • Command Brands Gel AntiBac Instant Hand Sanitizer has been recalled by Roque Plast S.A. de C.V. due to the potential presence of methanol.
  • Jaloma Antiseptic Hand Sanitizer has been recalled by Laboratorios Jaloma S.A. de C.V. due to the presence of undeclared methanol, or wood alcohol.

July 2020 FDA Recalls

  • Herbacil Antiseptic Hand Sanitizer, 70% alcohol, has been recalled by Broncolin S.A. de C.V due to potential methanol contamination.
  • Assured, Blumen & Modesa Hand Sanitizer has been recalled by 4e Brands North America due to undeclared methanol, or wood alcohol.
  • Resource Recover & Trading Hand Sanitizer has been recalled by Resource Recover & Trading LLC due to undeclared methanol subpotency ethyl alcohol.
  • Born Basic, Scent Theory, et. al. Hand Sanitizer has been recalled by Real Clean Distribuciones SA de CV due to undeclared methanol.
  • Shine & Clean Hand Sanitizer Gel has been recalled by Maquiladora Miniara, S.A. de C.V. due to the potential presence of methanol, or wood alcohol.
  • Dexmedetomidine Hydrochloride Injection, 200 mcg/50ml, has been recalled by Fresenius Kabi Issues due to cross-contamination of lidocaine.
  • Optimus Hand Sanitizer has been recalled by LIQ-E S.A. de C.V. due to potential methanol contamination.
  • GlideScope Core One TouchSmart Cable (“OneTouch cable”) has been recalled by Verathon Inc. due to partial or complete loss of image during use.
  • bio aaa Advance Hand Sanitizer has been recalled by AAA Cosmetica, S.A. de C.V. due to potential undeclared methanol contamination.
  • Bersih Hand Sanitizer Gel Fragrance Free has been recalled by Soluciones Cosmeticas due to potential undeclared methanol contamination.
  • Blumen Advanced Hand Sanitizer has been recalled by 4e Brands North America due to the potential presence of methanol, or wood alcohol.
  • Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg, have been recalled by Lupin Pharmaceuticals Inc. due to an N-Nitrosodimethylamine (NDMA) impurity.
  • BodyGuard® Infusion System Administration Sets have been recalled by CME America due to potential overinfusion or underinfusion during use.
  • Ovation iX system has been recalled by Endologix® Inc. due to a weak material adjacent to the polymer fill causing leaks.
  • Daptomycin for Injection, 500 mg/vial, has been recalled by Mylan Institutional LLC due to the presence of particulate matter.
  • All Clean Hand Sanitizer, Moisturizer, and Disinfectant have been recalled by ITECH 361 due to the potential presence of methanol, or wood alcohol.
  • Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, have been recalled by Granules Pharmaceuticals Inc. due to an N-Nitrosodimethylamine (NDMA) impurity.
  • Arrow AutoCAT®2 and AC3 Optimus® Intra-Aortic Balloon Pump Series have been recalled by Arrow International Inc. due to possible breakdown of motor connector wires.

June 2020 FDA Recalls

  • Saniderm Advanced Hand Sanitizer, 70% alcohol content, has been recalled by UVT INC. due to the potential presence of methanol, or wood alcohol.
  • TTDeye colored contact lenses have been recalled by Chengdu Ai Qin E-commerce Co. Ltd due to distribution without FDA clearance.
  • Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough have been recalled by GSK Consumer Healthcare because of incorrect dosing cups.
  • Metformin Hydrochloride Extended-Release Tablets, USP 500mg, have been recalled by Lupin Pharmaceuticals Inc. due to an N-Nitrosodimethylamine (NDMA) impurity.
  • Metformin Hydrochloride Extended-Release Tablets, USP 500mg, have been recalled by Apotex Corp. due to an N-Nitrosodimethylamine (NDMA) impurity.
  • Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg, have been recalled by Teva Pharmaceuticals USA Inc. due to an N-Nitrosodimethylamine (NDMA) impurity.
  • Metformin Hydrochloride Extended-Release Tablets, USP 500mg, have been recalled by Marksans Pharma Limited, India due to an N-Nitrosodimethylamine (NDMA) impurity.
  • Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg, have been recalled by Amneal Pharmaceuticals LLC due to an N-Nitrosodimethylamine (NDMA) impurity.
  • Biocell textured breast implants and tissue expanders have been recalled by Allergan Aesthetics due to an increased risk of BIA-ALCL.

May 2020 FDA Recalls

  • HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief have been recalled by Medtronic due to the risk of breaks and tears during assembly.
  • 30-mg, 60-mg and 90-mg NP Thyroid® have been recalled by Acella Pharmaceuticals LLC due to super potency.
  • Python Embolectomy Catheters, Bard Embolectomy Catheters, and the OTW Latis Cleaning Catheters have been recalled by Applied Medical due to the risk of catheter tips detaching during use.
  • Finasteride Plus 1.25mg capsules have been recalled by MasterPharm LLC due to the presence of an undeclared antihypertensive drug called minoxidil.

April 2020 FDA Recalls

  • Langston Dual Lumen Catheters have been recalled by Vascular Solutions Inc. due to the risk of inner catheter separation during use.
  • Infusion pumps and infusion sets have been recalled by CME America due to under-delivery of fluid and inaccuracy of pump delivery speed.
  • R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe has been recalled by QuVa Pharma, Inc. due to presence of particulate matter.
  • TRUE METRIX® AIR Blood Glucose Meter has been recalled by Trividia Health Inc. because of an incorrect factory-set unit of measure.
  • Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL have been recalled by Fresenius Kabi USA LLC due to presence of particulate matter.
  • Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container have been recalled by Braun Medical Inc. because of elevated levels of high molecular weight polymers.
  • Tetracycline HCl Capsules, 250mg and 500mg, have been recalled by Avet Pharmaceuticals Labs Inc. because of low dissolution results.
  • Nizatidine Oral Solution 15 mg/mL has been recalled by Amneal Pharmaceuticals LLC because of an NDMA (Nitrosodimethylamine) impurity.
  • Methylprednisolone Sodium Succinate for Injection, USP 40mg, 125mg, and 1g have been recalled by Sagent Pharmaceuticals because of an unidentified impurity.
  • Hydromorphone HCL Injection, USP CII have been recalled by Hospira Inc. because of the potential for empty or cracked glass vials.
  • Imager II 5F Angiographic Catheters have been recalled by Boston Scientific Corporation because the catheter tip could potentially become detached, which could lead to serious injury or even death.
  • LeMaitre Over the Wire Embolectomy Catheters have been recalled by LeMaitre Vascular Inc. because of balloon deflation and separation issues.
  • All prescription and over-the-counter ranitidine drugs from all manufacturers, including the common brand name Zantac, have been withdrawn entirely from the U.S. market at the request of the FDA.

March 2020 FDA Recalls

  • Pipeline flex embolization devices have been recalled by Medtronic because of a fracturing risk.
  • STAT-Check and Medline resuscitator bags have been recalled by SunMed Holdings because they were defective.
  • Phytonadione injectable emulsion USP, 10 mg/mL, single-dose ampules have been recalled by Dr. Reddy’s Laboratories, Ltd. because the ampules were breaking and shattering.
  • Organic kudzu root herbal supplements have been recalled by Mountain Rose Herbs because of a potential salmonella contamination.
  • Natural Remedies Active Male capsules have been recalled by the Natural Remedy Store because of the presence of undeclared Tadalafil.
  • Ketorolac Tromethamine Injections at 30mg has been recalled by Hikma Pharmaceuticals USA Inc. because of the potential presence of small particulates.

February 2020 FDA Recalls

  • Phenytoin Oral Suspension of 125 mg has been recalled by Taro Pharmaceuticals U.S.A., Inc. because of possible underdosing or overdosing of the drug.

January 2020 FDA Recalls

  • Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid have been recalled by Efficient Laboratories, Inc. because of microbial contamination.
  • Lamotrigine Tablets of 100mg have been recalled by Taro Pharmaceuticals U.S.A., Inc. because of cross-contamination with another drug substance, Enalapril Maleate.
  • Nizatidine Capsules of 150mg and 300mg have been recalled by Mylan N.V. because of an NDMA (Nitrosodimethylamine) impurity.

December 2019 FDA Recalls

  • Mirtazapine Tablets of 7.5mg strength have been recalled by Aurobindo Pharma USA, Inc. because of a label error for declared strength.
  • Levetiracetam Oral Solution has been recalled by Lannett Company, Inc. because of microbial contamination of Bacillus subtilis.
  • Men’s sexual supplements Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, Panther Platinum 30000 have been recalled by Motto International Corp because of the presence of undeclared Tadalafil.

November 2019 FDA Recalls

  • Blood administration kits have been recalled by B. Braun Medical, Inc. because of a potential leakage at the joint between the blood filter and tubing.
  • Ranitidine (commonly known under the brand name Zantac) has been recalled by multiple companies due to a potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA. Given the popularity of the drug, this is one of the most significant medication recalls of the year.
    Learn more about this Zantac recall on FDA.gov and Health.Harvard.edu.
  • Silver Bullet male enhancement capsules have been recalled by Nature’s Rx due to an unapproved active ingredient (sildenafil).
  • Up2 libido and dietary supplements have been recalled by Med Man Distribution because the product is tainted with sildenafil.
  • Viatrexx sterile injectable products have been recalled by Viatrexx Bio Incorporated because of a lack of sterility assurance.
  • Fagron Let’s Gel Kit Convenience Packs have been recalled by Fagron Inc. because they potentially contain microbial contamination in the nonsterile Saturagel.

View more recalls on FDA.gov

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Noble McIntyre

Noble McIntyre began practicing law in Oklahoma in 1995, and has spent his entire career exclusively devoted to representing the injured. Noble has built McIntyre Law into a practice that represents clients nationally in mass tort cases, as well as those injured in his cherished home community of Oklahoma. He leads a practice dedicated to obtaining just outcomes for the injured and his team has obtained multi-million-dollar settlements and judgments for clients. Read more about Noble McIntyre.

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