Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Pfizer is recalling Aminophylline Injection vials due to a complaint of particulate matter (hair) in one vial. Over 103,000 vials were distributed to the US and Puerto Rico.
Woodbine Products is recalling FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH due to incorrect scent information on the label. The affected lots VDAF017 and VDAF018 were distributed in North Carolina, and no illnesses have been reported.
Akorn is recalling Rifampin Capsules USP 300 mg (30-, 60-, and 100-count bottles) distributed nationwide because finished product exceeds the interim limit for 1-Methyl-4-Nitrosopiperazine impurity. The recall affects approximately 177,439 bottles.
Cipla recalls Budesonide Inhalation Suspension ampules due to inability to assure sterility. Affected lots GA20080, GA20081, and GA20094 expire January 2024.
Leading Pharma, LLC is recalling Clomipramine Hydrochloride Capsules (25mg) with Lot B14221 due to testing that found 110.6% of the labeled active ingredient strength. The medication was distributed nationwide.
QuVa Pharma is recalling oxytocin injections due to incorrect formulation. Bags contain 0.45% sodium chloride instead of the intended 0.9%.
Akorn, Inc. is recalling 18,145 bottles of Rifampin Capsules, USP 150 mg due to impurity levels exceeding the FDA's 5 ppm interim specification limit for 1-Methyl-4-Nitrosopiperazine (MNP).
Novartis is recalling Neoral cyclosporine 25 mg capsules nationwide due to a manufacturing quality deviation. Lot APCD162 (expiration 01/2023) was found to have out-of-specification ethanol content during stability testing.
Sun Pharmaceutical is recalling Esomeprazole Magnesium capsules nationwide because the drug potency exceeds the specified level at the 12-month timepoint.
ALMIRALL, LLC is recalling 5,315 tubes of Xolegel ketoconazole 2% gel because tests found the product failed viscosity specifications, with out-of-specification results showing values slightly higher than acceptable.
Sun Pharmaceutical is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg nationwide due to superpotency findings. Lot AC14299 (expiration 12/2022) tested out of specification for drug assay at the 12-month stability timepoint.
Viatris Inc recalls 3,931 cartons of Ampicillin for Injection after a complaint of a hair strand found in one vial. No illnesses have been reported.
UNICHEM PHARMACEUTICALS is recalling Clonidine Hydrochloride Tablets labeled 0.3 mg that contain 0.2 mg tablets instead. The recall affects 18,960 bottles (Lot # GCLH22005) distributed nationwide.
Meijer brand magnesium citrate laxative (10 fl oz) has been recalled nationwide due to microbial contamination of Lot 0557622. Consumers should discard or return the product.
Citroma magnesium citrate laxative is recalled due to microbial contamination. The FDA Class I recall affects 42,912 bottles distributed in the USA, Canada, and Panama.
Vi-Jon, LLC is recalling Walgreens Dye-Free Magnesium Citrate Saline Laxative due to microbial contamination of the non-sterile product. Approximately 29,172 bottles distributed nationwide in the USA, Canada, and Panama are affected.
Pfizer is recalling 5,390 vials of Propofol Injectable Emulsion due to the presence of particulate matter. The affected lot (EA7470, expiration 6/1/2023) was distributed nationwide.
CVS Health Magnesium Citrate Saline Laxative is being recalled due to potential microbial contamination of the non-sterile product. Approximately 241,086 bottles were distributed nationwide.
Edgewell Personal Care Brands is recalling Banana Boat hair & scalp defense Clear Sunscreen Spray SPF 30 due to benzene contamination. The affected product was distributed nationwide in the United States.
Equate Magnesium Citrate saline laxative has been recalled for microbial contamination. The FDA Class I recall affects 18,324 bottles distributed in the US, Canada, and Panama.
Vi-Jon's CITROMA magnesium citrate laxative is recalled due to microbial contamination. Approximately 18,588 bottles were distributed nationwide in the USA, Canada, and Panama.
Vi-Jon is recalling SWAN Citroma Magnesium Citrate Saline Laxative (10 FL OZ bottles) due to microbial contamination of a non-sterile product. The product was distributed nationwide in the USA, Canada, and Panama.
Kroger-branded Magnesium Citrate saline laxative is being recalled due to microbial contamination. The recall affects approximately 44,976 bottles distributed in the USA, Canada, and Panama.
Vi-Jon's Magnesium Citrate oral solution laxative is recalled nationwide due to microbial contamination. Approximately 8,682 bottles are affected.
Vi-Jon, LLC is recalling CITROMA magnesium citrate oral laxative solution due to microbial contamination. The affected product was distributed nationwide in the USA, Canada, and Panama.
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