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.
Mckesson is recalling Bicillin L-A prefilled syringes stored outside label specifications. The FDA Class II recall affects 70 vials distributed to direct accounts in NM, AZ, and UT.
Sun Pharmaceutical is recalling 7,488 bottles of Febuxostat 80mg tablets nationwide due to microbial contamination found in manufacturing equipment. No illnesses have been reported.
Global Corporation is recalling Broncochem Cold & Tea nationwide due to stability testing failures in the active ingredients. No illnesses or injuries have been reported.
Global Corporation is recalling Broncochem Cold & Flu Syrup Kids (120 mL bottles) nationwide due to stability testing failures in active pharmaceutical ingredients.
Eugia US LLC recalls methylprednisolone acetate injection due to failed dissolution specifications. Affected states: Ohio, Tennessee, Louisiana, and Mississippi.
Contract Pharmaceuticals Limited Canada is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak slowly. The product was distributed nationwide in the U.S. and Puerto Rico.
Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution 1% due to defective containers with slow leakage. Lot 119874 (expires 06/30/2025) distributed nationwide in the U.S. and Puerto Rico is affected.
Stason Pharmaceuticals recalls Mercaptopurine Tablets, USP 50 mg due to failed dissolution specifications at 9 months. Dissolution results were slightly below the required specification.
Lubricant PM Ointment is being recalled by AACE Pharmaceuticals due to the manufacturer's failure to assure the product was manufactured under sterile conditions.
CVS Health Lubricant Eye Ointment is being recalled nationwide due to lack of sterility assurance during manufacturing. The recall affects 159,334 units distributed in 3.5-gram tubes with lot numbers A2F03, A2I02, A2L02, A3C04, and A3H04.
Denver Solutions is recalling Moxifloxacin PF eye injection vials nationwide due to glass delamination in the vials. The affected product is used for eye surgery injections.
Denver Solutions is recalling 10,020 vials of Moxifloxacin 5mg/ml nationwide due to glass delamination in the vial packaging. Affected lots: 2331123 (exp. 2/28/24) and 2331298 (exp. 3/24/24).
Seatex LLC is recalling 1,282 cases of 7 Eleven Hand Sanitizer Gel due to manufacturing facility deficiencies found during FDA inspection. The product was distributed nationwide.
Bausch Health Companies is recalling 3,600 cartons of Omeprazole and Sodium Bicarbonate nationwide. The drug was found to be subpotent, containing less active ingredient than specified.
Equate Lubricant Eye Ointment, distributed nationwide by Walmart, is being recalled because the manufacturer cannot assure the product's sterility. The recall affects 315,842 units across multiple lots.
Sun Pharmaceutical is recalling Mesalamine extended-release capsules due to failed dissolution specifications. The affected capsules may not dissolve and release medication properly.
Denver Solutions is recalling Lidocaine-Phenylephrine injectable vials nationwide due to glass delamination in the vials. The defect could potentially introduce glass fragments into the medication.
Equate Stye Lubricant Eye Ointment is being recalled due to lack of assurance of sterility. Approximately 355,633 units have been distributed nationwide and are affected.
The FDA is recalling Fluticasone Propionate Nasal Spray due to suspected potential presence of Burkholderia cepacia complex bacteria. The affected lot (TX5275) was distributed nationwide.
A hand sanitizer distributed to 7-Eleven gas stations nationwide is being recalled due to manufacturing deficiencies identified during an FDA inspection. The affected product is lot 251176, distributed in the United States and Puerto Rico.
Seatex LLC is recalling PROBLEND Hand Sanitizer (Lot 266029) nationwide due to manufacturing deficiencies identified during FDA inspection.
Seatex LLC is recalling 1,450 cases of PROBLEND Antibacterial Foaming Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations discovered at its manufacturing facility. The recall affects product distributed nationwide in the United States and Puerto Rico.
Seatex LLC is recalling PROBLEND E3 Foaming Hand Sanitizer due to manufacturing practice deviations identified during FDA inspection. The recall affects products distributed nationwide in the US and Puerto Rico.
Insight Pharmaceuticals is recalling TING 1% Tolnaftate Athlete's Foot Spray due to benzene contamination. The recall affects approximately 59,644 cans distributed nationwide.
Neptune's Fix Tianeptine Elixir has been recalled because it contains tianeptine, an unapproved drug substance in the United States. Approximately 1 million bottles distributed nationwide are affected.
Looking for a different category? Browse all recalls.