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.
Crestline Pharmaceuticals is recalling two lots of warfarin sodium tablets after a labeling error swapped 2.5 mg and 5 mg strengths.
Somerset Therapeutics is recalling Pemetrexed for Injection 100mg/Vial due to lack of sterility assurance. The recall affects approximately 12,000 vials distributed nationwide.
Bortezomib for Injection 3.5mg/Vial manufactured by Reliance Life Sciences is being recalled nationwide due to lack of sterility assurance. Affected lots include RBIH0125A, RBIH0225A, RBIH0325A, and RBIH0525A distributed across the USA.
Reliance Life Sciences is recalling Pemetrexed for Injection 500mg/Vial nationwide due to lack of sterility assurance. The affected product may not meet required sterility standards for intravenous use.
Reliance Life Sciences is recalling Azacitidine for Injection 100mg/Vial nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% is recalled nationwide because the product is subpotent. The manufacturer Gasco Industrial Corp. initiated this voluntary recall.
Shimoga Chemicals is voluntarily recalling Clomiphene Citrate USP active pharmaceutical ingredient in three package sizes due to current good manufacturing practice (cGMP) deviations. The product was distributed in California and Florida.
Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (32 oz.) due to subpotency. Affected lots 250206B1, 250218B2, and 250507B1 were distributed nationwide in the US.
Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (32 oz bottles, Lot 250218B3) distributed nationwide because the product is subpotent—containing less active ingredient than labeled.
Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (1 gallon) due to subpotency. The affected lots are 250221A5 and 250224A2 distributed nationwide.
Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (1 US Gallon) nationwide due to subpotency. The voluntary recall affects specific lot numbers manufactured before the expiration date.
QuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL compounded drug vials due to failed impurities and degradation specifications. The recall affects multiple lot numbers distributed nationwide.
Medline Remedy Specialized Silicone Cream is being recalled because formaldehyde levels exceeded the product specification. BioMed Laboratories is recalling approximately 509,652 tubes distributed nationwide.
Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (16 oz bottles, Lot 250306B3) nationwide because the product is subpotent. Consumers should stop using the affected product and contact their healthcare provider if they have health concerns.
OneSource Specialty Pharma Limited is recalling one lot of Methohexital Sodium for Injection due to failed impurities and degradation specifications. The affected product was distributed nationwide.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide. The products were unsterilized and distributed outside the intended channel intended for further processing and sterilization.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.
Asclemed USA Inc. is recalling specific lots of Accucaine (Lidocaine HCl Injection USP, 1%) distributed nationwide due to lack of assurance of sterility. The affected product is distributed by Enovachem Pharmaceuticals.
Revitaderm Wound Care Gel has been recalled due to microbial contamination with Lysinibacillus fusiformis and other Bacillus species. The product was distributed nationwide and consumers should stop using it.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.
CareFusion is recalling ChloraPrep One-Step antiseptic applicators because unsterilized units intended for further processing were distributed outside the intended channel, creating a sterility assurance gap.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators distributed nationwide because unsterilized units intended for further processing were shipped to customers outside the intended distribution channel.
Asclemed USA Inc. is recalling Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) in 5 mL single dose ampules nationwide due to lack of assurance of sterility. The affected lots have expiration dates of 11/30/2026 and 04/30/2028.
CareFusion 213, LLC is recalling PurPrep sterile applicators distributed nationwide because unsterilized units intended for further processing were distributed to customers outside the intended channel.
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