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.
Pending LLM rewrite. Source: FDA_DRUG D-0504-2025.
Pending LLM rewrite. Source: FDA_DRUG D-0502-2025.
Pending LLM rewrite. Source: FDA_DRUG D-0508-2025.
Pending LLM rewrite. Source: FDA_DRUG D-0500-2025.
Pending LLM rewrite. Source: FDA_DRUG D-0498-2025.
Pending LLM rewrite. Source: FDA_DRUG D-0570-2025.
Pending LLM rewrite. Source: FDA_DRUG D-0528-2025.
The Harvard Drug Group LLC is recalling 23,232 cartons of Gabapentin Capsules 100 mg (Lot# M05205, Exp Date 10/2026) distributed nationwide due to inadequately sealed blister packaging that may compromise product integrity.
Teva Pharmaceuticals is recalling Pitavastatin 2 mg tablets manufactured by Orient Pharma due to failed impurities and degradation specifications.
AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.
Thrive Health and Wellness, LLC is recalling LL Bioboost Injectable pre-filled syringes nationwide due to lack of assurance of sterility. The affected product is Lot #H277639 with expiration 6/25/2025.
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200 (Testosterone Cypionate Injection USP, 200mg/ml) because it was marketed without an approved NDA or ANDA.
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection in flexible plastic containers nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
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.
Thrive Health Solutions is recalling Tirzepatide Injections (10mg/mL, pre-filled syringes) distributed nationwide due to lack of assurance of sterility. Consumers should not use the affected product and contact their healthcare provider.
Thrive Health Solutions is recalling one lot of Tirzepatide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected product is Lot C03125A 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.
Apotex Corp. is recalling Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% due to lack of assurance of sterility. The affected batch was distributed nationwide.
Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5% due to lack of assurance of sterility. The recall affects 87,840 bottles distributed nationwide.
Thrive Health Solutions is recalling Semaglutide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected lot was distributed nationwide.
Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot #O-O8A01-25) distributed nationwide due to lack of assurance of sterility. Consumers should not use this product.
Apotex Corp. is recalling 6,288 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution nationwide due to lack of assurance of sterility. The affected batch (VC6058, expiration date 10/31/2025) does not meet sterility requirements for ophthalmic use.
Thrive Health Solutions is recalling CJC-1295 Injectable 6mg/15mg pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.
Thrive Health Solutions is recalling LX Bioboost Plus pre-filled syringes due to lack of assurance of sterility. The affected product is a multi-ingredient injectable formulation 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.
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