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.
The FDA has recalled Methotrexate intravitreal injectable from Pharmacy Innovations due to lack of assured sterility. An FDA inspection revealed insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution nationwide due to insanitary facility conditions that compromised sterility assurance. Consumers should discontinue use and contact their healthcare provider.
Pharmacy Innovations has recalled papaverine/phentolamine injectable vials in multiple concentrations due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling injectable Vitamin D3 products nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.
FDA is recalling BSS Plus/Lidocaine Opth 1% injectable syringes manufactured by Pharmacy Innovations due to lack of sterility assurance found during a facility inspection.
Pharmacy Innovations is recalling polidocanol injectable vials nationwide after FDA inspection revealed insanitary conditions at the manufacturing facility that compromised sterility assurance.
Pharmacy Innovations recalls Phenol 10% injectable vials distributed nationwide due to insanitary conditions at the manufacturing facility that compromised sterility assurance.
Pharmacy Innovations recalls multiple injectable estradiol and testosterone products due to insanitary facility conditions that compromise sterility assurance. The products were distributed nationwide.
Pharmacy Innovations is recalling three injectable vitamin B-complex products nationwide due to insanitary conditions discovered during FDA inspection. The products lack assurance of sterility and may pose contamination risk.
Pharmacy Innovations recalls Tacrolimus ophthalmic solutions nationwide due to potential sterility assurance issues from insanitary facility conditions found during FDA inspection.
Pharmacy Innovations is recalling Mitomycin 0.2mg/ml ophthalmic solution nationwide due to lack of sterility assurance following FDA facility inspection findings.
Pharmacy Innovations is recalling vancomycin fortified ophthalmic solutions nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.
LEVEMIR injectable insulin is being recalled nationwide due to insanitary facility conditions that compromise sterility assurance. FDA inspection identified conditions that may affect product safety.
Pharmacy Innovations is recalling Cyclosporine ophthalmic solutions (0.1%, 0.2%, 1%, 2%, and corn-oil-based 1%) due to lack of sterility assurance. FDA inspection found insanitary facility conditions.
Pharmacy Innovations recalls a polyhexamethylene biguanide eye-drop solution nationwide due to insanitary manufacturing conditions. No illnesses have been reported.
Pharmacy Innovations is recalling multiple glutathione products due to insanitary facility conditions that compromise sterility assurance. The recall affects inhalation and injectable formulations distributed nationwide.
Pharmacy Innovations is recalling magnesium chloride hexahydrate injectable (5 mL vials) distributed nationwide due to insanitary facility conditions that compromise product sterility assurance.
Pharmacy Innovations has recalled Chlorpheniramine/Hyoscyamine injectable medication nationwide due to insanitary facility conditions identified during FDA inspection that compromise product sterility.
Pharmacy Innovations recalls two concentrations of atropine sulfate eye drops due to insanitary facility conditions discovered by FDA inspection. The products were distributed nationwide.
Pharmacy Innovations is recalling Hydroxocobalamin 25MG/ML injectable vials nationwide due to insanitary facility conditions identified during FDA inspection that compromise sterility assurance.
Pharmacy Innovations is recalling Mitomycin ophthalmic solutions nationwide due to a lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling Lidocaine-PF 5% injectable solution nationwide due to insanitary facility conditions that compromised sterility assurance, discovered during FDA inspection.
Pharmacy Innovations is recalling Acetylcysteine 10% Ophthalmic Solution nationwide due to FDA-identified insanitary manufacturing conditions that compromise product sterility. Affected batches include codes t20221011@36 and t20221108@24.
Pharmacy Innovations is recalling Gentamicin bladder irrigation solutions due to FDA findings of insanitary facility conditions that compromised sterility assurance during manufacturing.
Pharmacy Innovations is recalling Ketamine 50mg/ml injectable vials nationwide due to insanitary facility conditions that compromised sterility assurance.
Looking for a different category? Browse all recalls.