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 Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate 10mg tablets nationwide due to N-nitroso impurity levels exceeding FDA acceptable limits, affecting 13,296 cartons.
Bryant Ranch Prepack is recalling 61 bottles of Cephalexin for Oral Suspension due to a back label stating an incorrect dose amount—5g instead of 10g per bottle.
GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.
Rising Pharma's pregabalin capsules are being recalled nationwide after a pantoprazole tablet was discovered during packaging. No illnesses have been reported.
Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.
Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.
Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.
Bryant Ranch Prepack is recalling Cephalexin oral suspension (125mg/5mL) due to back label errors stating the dose as 2.5g instead of the correct 5g per bottle. No illnesses have been reported.
Cephalexin for Oral Suspension is being recalled due to a back label error. The label states 'Each contains' instead of 'Each Bottle contains,' affecting 190 bottles distributed nationwide.
Bryant Ranch Prepack is recalling Cephalexin oral suspension bottles due to incorrect labeling that states tablet information instead of liquid suspension details and omits the total dose per bottle.
Revive Rx Pharmacy recalls 751 vials of compounded tirzepatide (Lot #748127) labeled to contain tirzepatide but actually filled with testosterone cypionate. Patients receiving this medication may take the wrong drug with serious health consequences.
ARG Laboratories is recalling Pain Wizard pain relief cream due to propylene glycol used in manufacturing not meeting pharmaceutical grade specifications. The product was distributed nationwide.
Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to defective container seals. The recall affects 51,006 bottles distributed nationwide with lot numbers F305184, F305185, and F305186.
ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to an active ingredient that does not meet specifications and violative grade propylene glycol used during manufacturing.
Imprimis NJOF, LLC is recalling preservative-free intraocular injection vials of Dexamethasone-Moxifloxacin due to lack of assurance of sterility. Approximately 39,700 vials were distributed nationwide.
Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine preservative-free intraocular injection vials (74,440 units) nationwide due to lack of sterility assurance.
Rubicon Research is recalling 11,664 bottles of Metoprolol Tartrate 25mg tablets nationwide due to the presence of metal in the tablets. Consumers should discontinue use and contact their healthcare provider.
ARG Laboratories is recalling Bull Frog SPF 50 Amphibious Lotion nationwide due to the active ingredient being out of specification. Consumers with affected lots should not use the product and contact the manufacturer.
Dr. Reddy's Laboratories recalls Zoledronic Acid Injection 5mg/100mL due to lack of sterility assurance and leaking vials. Lot #G3000010 with 13,880 vials was distributed nationwide.
Imprimis NJOF, LLC recalls Moxifloxacin intraocular injection vials nationwide due to lack of sterility assurance. The 18,980 affected vials (lot 23OCT013) should not be used.
Imprimis NJOF, LLC is recalling Dexamethasone-Moxifloxacin-Ketorolac intraocular injections (38,060 vials) due to lack of assurance of sterility. The affected lots were distributed nationwide.
ARG Laboratories' Natural Pain Relieving Cream Golden Tiger is being recalled due to out-of-specification active ingredient and improper-grade propylene glycol used in manufacturing. No illnesses have been reported.
Imprimis NJOF, LLC is recalling 14,180 vials of Epinephrine-Lidocaine intraocular injection due to lack of assurance of sterility. These vials were distributed nationwide within the United States.
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