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.
Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found contaminated with benzene.
Bayer Healthcare is recalling LOTRIMIN AF Jock Itch Powder Spray (Miconazole nitrate 2%, 4.6 OZ cans) distributed nationwide due to manufacturing facility cGMP deviations where other lots were found to be contaminated with benzene.
Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Powder Spray due to potential benzene contamination from cGMP deviations at the manufacturing facility. The recall affects approximately 2.8 million cans distributed nationwide and internationally.
Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate) spray due to potential benzene contamination from manufacturing facility cGMP deviations. The product was distributed nationwide and internationally.
Bayer Healthcare is recalling Lotrimin AF Miconazole nitrate 2% Liquid Spray nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to contain benzene.
Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) liquid spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.
Teva Pharmaceuticals USA is recalling Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg due to an incorrect expiration date printed on the label. The affected lot was distributed nationwide.
Teva Pharmaceuticals USA is recalling 64,978 Clonidine Transdermal System patches (0.1 mg/day) due to failed specifications for impurities and degradation. The recall affects nationwide and Puerto Rico distribution.
Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil due to an out-of-specification assay result indicating the drug is subpotent and may not deliver the intended therapeutic dose.
Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil because testing found out-of-specification assay results, meaning the drug may contain less active ingredient than labeled.
Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF Daily Prevention deodorant powder spray due to cGMP deviations at the manufacturing facility where other lots were found contaminated with benzene.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Sermorelin Acetate 9mg/Ipamorelin 9mg lyophilized vials (Lot 08102021:22) distributed in the United States due to lack of assurance of sterility.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 30mcg/ml injectable due to lack of assurance of sterility. The product was distributed in the United States including Washington, D.C. and Puerto Rico.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable product containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects lot T1009092021:19 distributed across the United States.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 INJ due to lack of assurance of sterility. The recall affects one lot distributed across the United States, Washington D.C., and Puerto Rico.
Talon Compounding Pharmacy is recalling TRI-MIX injectable medication because the manufacturer cannot assure that the product meets sterility requirements. Affected patients should consult their healthcare provider immediately.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-TEST 200 injectable medication due to lack of assurance of sterility. Affected lots include T1007302021:37 and T1008242021:04.
Talon Compounding Pharmacy is recalling a testosterone cypionate combination injectable product distributed nationwide due to lack of assurance of sterility, which could pose risk of serious infection.
Talon Compounding Pharmacy is recalling an injectable steroid combination product (Test Cypionate 200mg/Anastrozole 2mg/Dutasteride 2mg/mL) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine/Phentolamine/PGE-1 injectable vials distributed across the United States and Puerto Rico due to lack of assurance of sterility.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 30mg/mL injectable due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington D.C., and Puerto Rico.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 20 mg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 injectable due to lack of assurance of sterility.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
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