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.
Glenmark Pharmaceuticals is recalling Rufinamide 200mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects certain lot numbers with July 2025 expiration dates.
Glenmark Pharmaceuticals is recalling solifenacin succinate 10mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects specific lot numbers distributed across the United States.
Glenmark Pharmaceuticals is voluntarily recalling Pravastatin Sodium 80mg tablets due to Current Good Manufacturing Practice deviations. The nationwide recall affects specific lot numbers and remains ongoing.
Glenmark Pharmaceuticals is voluntarily recalling Prochlorperazine Maleate 10mg tablets (NDC# 68462-890-01) distributed nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.
Glenmark Pharmaceuticals is voluntarily recalling Rosuvastatin Calcium 40mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lot numbers expiring February through June 2026.
Glenmark Pharmaceuticals is recalling Ranolazine Extended-Release 1000mg tablets (Lot 17240040) nationwide due to manufacturing deviations. This is a voluntary, firm-initiated recall.
Glenmark Pharmaceuticals is voluntarily recalling Voriconazole tablets nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.
Glenmark Pharmaceuticals Inc. USA is recalling Clindamycin Hydrochloride Capsules, USP 300mg due to CGMP deviations. The product has been distributed nationwide.
Asegua Therapeutics is recalling 18,541 cartons of Sofosbuvir and Velpatasvir tablets nationwide due to defective blister packs that are not properly sealed, resulting in loose tablets in cartons. No illnesses or injuries have been reported.
Kramer Laboratories recalls Safetussin Max Strength Multi-Symptom Cough, Cold and Flu blister packs due to packaging that fails to resist child access. Tablets can be pushed through the foil, posing a poisoning risk to young children.
Breckenridge Pharmaceutical is recalling Duloxetine 30 mg capsules distributed nationwide due to a nitrosamine impurity above acceptable limits. Consumers should consult their doctor about their medication.
Biocon Pharma is recalling 2,184 bottles of Atorvastatin Calcium Tablets USP 40 mg nationwide. The product failed to meet required dissolution specifications, which may affect medication absorption.
Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets due to a manufacturing quality deviation involving an impurity above recommended limits.
Imprimis NJOF is recalling 2,822 bottles of sterile ophthalmic solution because stability testing showed subpotent drug strength below specifications.
Tolterodine Tartrate Extended-Release Capsules, 2 mg (Lot T05393) are being recalled because they failed dissolution specifications. The capsules may not dissolve as intended.
Amerisource Health Services is recalling Voriconazole 50 mg tablets distributed nationwide due to current Good Manufacturing Practice deviations related to repackaging.
Ascent Consumer Products Inc. is recalling SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System nationwide due to bacterial contamination with Staphylococcus aureus. Affected lot number is 024122661Al with expiration date 12/2027.
SinuCleanse Premixed Saline Packets sold nationwide are being recalled due to contamination with Staphylococcus aureus, a bacterium that can cause infection.
QuVa Pharma recalls compounded fentanyl and bupivacaine epidural injections due to lack of sterility assurance. Affected lots distributed nationwide pose potential infection risks.
Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.
QuVa Pharma recalls compounded fentanyl-bupivacaine epidural injections due to lack of assurance of sterility. The recall affects 2,310 cassettes distributed nationwide.
Strides Pharma is recalling Testosterone Gel 1% nationwide due to the presence of benzene, a toxic substance. Patients should contact their healthcare provider about alternative treatment options.
QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.
A-S Medication Solutions is recalling 411 bottles of Metformin Hydrochloride Extended-Release 500mg tablets (Lot #4260340) distributed nationwide due to the presence of foreign tablets or capsules.
Babyganics Sheer Blend SPF 50 Mineral Sunscreen is being recalled nationwide because ingredients separated during stability testing, prompting an FDA Class II recall.
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