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.
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Kirkland Signature AllerClear D 24 HR (Loratadine and Pseudoephedrine Sulfate) tablets nationwide because the product failed to meet moisture content limits.
Ultra Seal Corporation is recalling Vica-Cet Back Pain Relief tablets nationwide because certain lots failed stability testing and contain out-of-specification levels of Salicylic Acid, an aspirin-related compound.
Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The recall affects 38,328 cans distributed nationwide.
Beiersdorf Inc. is recalling Coppertone Pure & Simple Baby 50 Sunscreen Spray nationwide due to the presence of benzene, a chemical contaminant. Consumers should stop using affected products immediately.
Beiersdorf Inc. is recalling Coppertone SPORT MINERAL 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The recall affects 142,236 cans distributed nationwide.
Beiersdorf Inc. is recalling Coppertone SPORT Sunscreen Spray 50 (1.6 oz cans) nationwide due to the presence of benzene, a known carcinogen. Affected lot TN00BU3 expires 05/31/2024.
Teva Pharmaceuticals is recalling AirDuo Digihaler 55/14 inhalation powder due to subpotent emitted dose of salmeterol. Approximately 1,978 inhalers distributed nationwide may deliver less medication than labeled.
Beiersdorf Inc. is recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The affected product was distributed nationwide.
Lupin Pharmaceuticals is recalling approximately 1,902 bottles of Imipramine Pamoate Capsules 125 mg due to out-of-specification results in dissolution testing at the 9-month stability checkpoint.
Beiersdorf Inc. is voluntarily recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 70,320 cans distributed nationwide.
American Health Packaging is recalling GlipiZIDE Extended-Release Tablets 2.5 mg (Lot #194141) nationwide because dissolution test results exceeded specification, which may affect the drug's effectiveness.
Teva Pharmaceuticals is recalling AirDuo Digihaler 232/14 inhalation powder because some units do not deliver the correct amount of salmeterol as labeled.
Dr. Reddy's Laboratories is recalling Acid Reducer (Omeprazole Magnesium) 20 mg capsules nationwide because staples have been found co-mingled with capsules in bottles.
Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some units contain less salmeterol than the labeled dose. The affected sample batch was distributed nationwide.
Beiersdorf Inc. is recalling 14,748 cans of Coppertone Pure & Simple baby 50 Sunscreen Spray due to cGMP (current Good Manufacturing Practice) deviations. The product was distributed nationwide.
Teva Pharmaceuticals is recalling approximately 5,500 units of AirDuo Digihaler 232/14 inhalation powder distributed nationwide because some inhalers contain less salmeterol than the labeled dose.
Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some batches do not deliver the labeled amount of salmeterol, a critical active ingredient for asthma and COPD control.
Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) due to contamination from Current Good Manufacturing Practice (CGMP) deviations. Use may cause skin or soft tissue infection and irritation.
Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to manufacturing practice deviations. Approximately 36,660 cans were distributed nationwide.
Piramal Critical Care is recalling Rocuronium Bromide Injection because the finished product vial lacks the required "WARNING: PARALYZING AGENT" statement on the flip cap. The missing warning could lead to unsafe use of this prescription neuromuscular-blocking drug.
SSM Health Care St. Louis is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride injection due to lack of assurance of sterility. The affected lot was distributed in Missouri.
Eli Lilly is recalling Glucagon Emergency Kits (Lot #D239382D, expiration April 2022) because some vials contain liquid instead of powder and do not deliver the full expected drug effect when administered.
Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.
AMIVAS (US), LLC is recalling Artesunate for Injection (110 mg/vial) because an air filter failed post-integrity testing, creating a lack of sterility assurance for the product.
Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.
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