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.
B Braun Medical Inc. is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to potential sterility failures caused by pinholes in finger boxes during manufacturing. The defect may allow leaks and compromise the sterile nature of the intravenous medication.
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200 (Testosterone Cypionate Injection USP, 200mg/ml) because it was marketed without an approved NDA or ANDA.
Thrive Health Solutions is recalling Tirzepatide Injections 30mg/mL pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.
Thrive Health Solutions is recalling Methylcobalamin Injectable 10mg/mL pre-filled syringes (Lot #H228307, expiration 12/27/2025) due to lack of assurance of sterility. The affected product was distributed nationwide.
Thrive Health Solutions is recalling Semaglutide 2.5 mg/mL pre-filled syringes (Lot #H270221) because the manufacturer cannot assure sterility of the product.
Pfizer is recalling one lot of Dobutamine Injection (250 mg/20 mL) nationwide due to discoloration and discolored solution caused by cracked vials. Healthcare facilities should quarantine and return affected units.
Thrive Health Solutions is recalling Tirzepatide Injections 20mg/mL pre-filled syringes due to lack of assurance of sterility. Approximately 826 syringes distributed nationwide are affected.
Protrim Plus dietary supplement 90-capsule bottles contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules. The product was distributed nationwide and may pose a risk to consumers with dye sensitivities or allergies.
Preventics, Inc. dba Legere Pharmaceuticals is recalling NutriLean dietary supplements nationwide because the gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) food dyes, which are not listed on the label.
UMOVY ACIDO HIALURONICO dietary supplement has been recalled because it contains undeclared prescription ingredients Dexamethasone and Diclofenac. The product was marketed without FDA approval.
UNAVY ACIDO HIALURONICO hyaluronic acid supplement is being recalled because it contains three undeclared pharmaceutical ingredients: Dexamethasone, Diclofenac, and Omeprazole. The product was marketed without FDA approval and poses health risks from the unlisted drugs.
Eugia US LLC is recalling Gentamicin Injection, USP (Pediatric), 20 mg per 2 mL due to failed color absorbance test results during 12-month stability analysis. The recall affects 48,000 vials distributed nationwide.
Aurobindo Pharma USA Inc is recalling Amazon Basic Care Acetaminophen 325 mg tablets due to confirmed consumer complaints of brown surface discoloration on tablets, a cGMP deviation.
Alembic Pharmaceuticals is recalling Celecoxib 200 mg capsules after a customer found a Tadalafil 5 mg tablet inside a sealed 500-count bottle. The contamination was discovered through a customer complaint.
Amneal Pharmaceuticals is recalling Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg) nationwide due to microbial contamination that may cause black spots on tablets. The contamination affects non-sterile products distributed across the USA.
SAINI TRADE INC is recalling ELECTRO BUZZ dietary supplement (lot KT-1ST-43-01-07/2024, expiring 10/15/2026) distributed nationwide. Laboratory testing found undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
MALEXTRA Recharge with Extra dietary supplement is being recalled nationwide because laboratory testing found undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil in the product.
Male Ultra Pro capsules are being recalled because laboratory testing found undeclared propoxyphenylsildenafil and sildenafil. The product was marketed without an approved New Drug Application.
ULTRA ARMOR dietary supplement, distributed by Health Fixer, is recalled nationwide because it contains undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.
Male Ultra dietary supplement, distributed nationwide in 3,000 boxes, has been recalled because laboratory testing found it contains undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.
AvKARE is recalling Celecoxib 200 mg capsules because one tadalafil 5 mg tablet was found in a 500-count bottle. The contamination poses a risk of unintended drug exposure to patients.
NRC Nutrition Pty Ltd is recalling Preconception Multi for Women 60 capsules, Batch 42469, due to inconsistent blending of iodine in the product.
AvKARE is recalling Chlorthalidone Tablets USP 25 mg due to failed dissolution specifications. The defect may affect the drug's therapeutic effectiveness.
Ascend Laboratories is recalling Cephalexin for Oral Suspension due to failed impurity specifications identified during stability testing. An out-of-specification result for Cephalexin Glucose Adduct was observed at six months.
Zydus Pharmaceuticals is recalling Icosapent Ethyl Capsules due to burnt or melted capsules caused by oxidation from leakage of capsule contents. The recall affects 11,616 bottles distributed in Illinois, Pennsylvania, and Mississippi.
Looking for a different category? Browse all recalls.