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.
AMBI Skincare Fade Cream Oily Skin (2 OZ) is recalled nationwide due to improper storage temperature. The product was stored outside the temperature requirements specified on its label.
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing. The affected products include lot numbers 2110053 and 2110115, representing 60 units distributed nationwide.
Busse Convenience kits containing swab and swabstick drug products are recalled nationwide due to uncertainty about whether manufacturing test methods were adequately validated.
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation. Products were distributed nationwide.
Busse Hospital Disposables recalls Universal Nerve Block Trays and swab products manufactured by PDI due to uncertainty regarding manufacturing test method validation.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.
Family Dollar Stores is recalling Luxury Hygiene Hand Sanitizer due to storage outside of labeled temperature requirements, which may affect product efficacy.
Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing.
Family Dollar is recalling an AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer (SPF 30) for improper storage. The product may have reduced efficacy.
Busse Hospital Disposables is recalling Universal Nerve Block Tray units (catalog 9779) due to uncertainty regarding test method validation in manufacturing the included swab/swabstick drug products. No illnesses or injuries have been reported.
Family Dollar Stores is recalling Luxury Hygiene Hand Sanitizer Moisturizing Formula due to cGMP deviations related to improper storage outside labeled temperature requirements.
Family Dollar Stores is recalling AMBI Skincare Even & Clear Exfoliating Wash because the product was stored outside labeled temperature requirements during manufacturing. No illnesses have been reported.
Family Dollar and Johnson & Johnson Consumer are recalling Aveeno Daily Moisturizing Lotion due to cGMP violations involving improper storage temperature. No illnesses have been reported.
Strides Pharma is recalling approximately 200,407 bottles of Losartan Potassium 25 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits.
Busse Hospital Disposables is recalling convenience kits containing swab products due to uncertainty about adequate validation of manufacturing test methods.
Busse Convenience kits containing swab/swabstick drug products made by PDI are being recalled due to uncertainty about validation testing adequacy in manufacturing. Users should discontinue use of affected lot numbers.
Busse Convenience kits containing swab and swabstick drug products manufactured by PDI are recalled due to uncertainty about manufacturing test method validation. No illnesses have been reported.
Busse Hospital Disposables is recalling Procedure Tray Catalog 1065 nationwide due to uncertain validation of manufacturing test methods for the swab/swabstick drug products inside.
Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.
Benzonatate 100mg capsule bottles are mislabeled. Some contain Benzphetamine tablets instead, and vice versa. This medication mix-up affects 10 bottles distributed to one physician in Alpharetta, Georgia.
Olympia Compounding Pharmacy recalls T-106 injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled product was distributed to Florida.
Olympia Compounding Pharmacy recalls 911 vials of Ondansetron Hydrochloride (1 mg/mL) due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling pharmaceutical diluent vials due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Preferred Pharmaceuticals is recalling specific lots of Losartan Potassium & HCTZ Tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled tablets were distributed in Florida and California.
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