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.
Accord Healthcare is voluntarily recalling Levothyroxine Sodium 300 mcg tablets because they may contain less active ingredient than labeled.
B. Braun Medical Inc. is recalling 23,688 bags of Lactated Ringer's Injection USP due to the presence of particulate matter.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 50 mcg tablets nationwide because they may contain less than the labeled amount of active ingredient.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium tablets because they may contain less active ingredient than labeled.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 200 mcg tablets because they are subpotent. The recall covers distribution nationwide in the United States.
Mallinckrodt is recalling ACTHAR Gel vials due to the presence of glass and stopper pieces. Patients should stop using the product and contact their healthcare provider.
Fresenius Kabi is recalling Tyenne (tocilizumab-aazg) injection vials because an internal investigation found the presence of glass particles.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 100 mcg tablets because they may contain less active ingredient than labeled.
Church & Dwight is recalling Zicam Cold Remedy Nasal Swabs because FDA inspections found out-of-limit microbiological testing results at the contract manufacturer.
Accord Healthcare is recalling specific lots of Levothyroxine Sodium 137 mcg tablets because they may contain less than the labeled amount of active ingredient.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 125 mcg tablets because they are subpotent. The recall is ongoing nationwide.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium tablets because they may contain less active ingredient than labeled.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 112 mcg tablets because they are subpotent. The recall covers nationwide distribution.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 75 mcg tablets nationwide because they may contain less than the labeled amount of active ingredient.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 25 mcg tablets nationwide because they are subpotent.
Beak & Skiff Sanitizer Alcohol Antiseptic 80% is being recalled because FDA analysis found acetaldehyde above specification limits in the product. The recall affects bottles distributed in New York and through online sales.
Hikma Pharmaceuticals is recalling specific lots of Ramipril 10 mg capsules because they failed impurity specifications for dicyclohexylurea.
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% because it failed content uniformity specifications. The recall covers 5,082 tubes distributed nationwide.
Apotex Corp. is recalling 6,972 bottles of Paxil CR 37.5mg tablets because the product failed dissolution specifications and 24-month stability testing.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 150 mcg tablets because they may contain less active ingredient than labeled.
American Regent, Inc. is recalling Papaverine Hydrochloride Injection due to the presence of glass and/or paraformaldehyde particulate matter.
Fresenius Kabi is recalling 625,500 Morphine Sulfate syringes because some were mislabeled and contained Dilaudid instead.
American Regent is recalling Multrys (Trace Elements Injection 4) vials due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling 43,460 vials of Nicardipine Hydrochloride Injection due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling Atropine Sulfate injection vials because they contain particulate matter, including hair, glass, and paraformaldehyde.
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