Browse Drug Recalls

471 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 471 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 471 FDA drug recalls.

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DateProductReasonClassFirm
May 18, 2016 Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compoun... cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration Class III Attix Pharmaceuticals Inc
Nov 14, 2014 Miltefosine active pharmaceutical ingredient packaged in varying grams or kg ... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Azithromycin Dihydrate active pharmaceutical ingredient packaged in varying g... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Bromocriptine Mesylate active pharmaceutical ingredient packaged in varying g... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Droperidol active pharmaceutical ingredient packaged in varying grams or kg i... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Meloxicam active pharmaceutical ingredient packaged in varying grams or kg in... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Isoproterenol Hydrochloride active pharmaceutical ingredient packaged in vary... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Hydralazine HCl active pharmaceutical ingredient packaged in varying grams or... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Atazanavir active pharmaceutical ingredient packaged in varying grams or kg i... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Monobenzone active pharmaceutical ingredient packaged in varying grams or kg ... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Roxithromycin active pharmaceutical ingredient packaged in varying grams or k... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Prazosin HCl active pharmaceutical ingredient packaged in varying grams or kg... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Vardenafil HCl Trihydrate active pharmaceutical ingredient packaged in varyin... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Tetracaine (free base) active pharmaceutical ingredient packaged in varying g... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Methscopolamine Bromide Combo active pharmaceutical ingredient packaged in va... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Mepivacaine HCl active pharmaceutical ingredient packaged in varying grams or... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Ezetimibe active pharmaceutical ingredient packaged in varying grams or kg in... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Cidofovir Anhydrous active pharmaceutical ingredient packaged in varying gram... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Prednisone active pharmaceutical ingredient packaged in varying grams or kg i... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Primaquine Phosphate active pharmaceutical ingredient packaged in varying gra... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Iron Sucrose or Ferric Hydroxide Sucrose Complex active pharmaceutical ingred... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Metformin HCl active pharmaceutical ingredient packaged in varying grams or k... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Itraconazole active pharmaceutical ingredient packaged in varying grams or kg... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Fluphenazine HCl active pharmaceutical ingredient packaged in varying grams o... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Vancomycin HCl active pharmaceutical ingredient packaged in varying grams or ... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Phenolphthalein active pharmaceutical ingredient packaged in varying grams or... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Thimerosal active pharmaceutical ingredient packaged in varying grams or kg i... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Carboplatin active pharmaceutical ingredient packaged in varying grams or kg ... Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/1... Class II Attix Pharmaceuticals
Nov 14, 2014 Fluconazole active pharmaceutical ingredient packaged in varying grams or kg ... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Celecoxib active pharmaceutical ingredient packaged in varying grams or kg in... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Retinoic Acid active pharmaceutical ingredient packaged in varying grams or k... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Labetalol HCl active pharmaceutical ingredient packaged in varying grams or k... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Hydroxocobalamin HCl active pharmaceutical ingredient packaged in varying gra... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Doxorubicin HCI active pharmaceutical ingredient packaged in varying grams or... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Tobramycin Base active pharmaceutical ingredient packaged in varying grams or... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Zolmitriptan active pharmaceutical ingredient packaged in varying grams or kg... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Leucovorin Calcium active pharmaceutical ingredient packaged in varying grams... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Zidovudine active pharmaceutical ingredient packaged in varying grams or kg i... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Metronidazole Benzoate active pharmaceutical ingredient packaged in varying g... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Levomefolate Calcium or L-5-Methyltetrahydrofolate Calcium active pharmaceuti... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Lomustine active pharmaceutical ingredient packaged in varying grams or kg in... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Dantrolene Sodium (Light Yellow) active pharmaceutical ingredient packaged in... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Pregelatinized Starch pharmaceutical ingredient packaged in varying grams or ... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Hydroxyzine HCl active pharmaceutical ingredient packaged in varying grams or... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Omeprazole Sodium active pharmaceutical ingredient packaged in varying grams ... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Digoxin active pharmaceutical ingredient packaged in varying grams or kg in b... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 L-Asparaginase active pharmaceutical ingredient packaged in varying grams or ... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Prednisolone Anhydrous Micronized active pharmaceutical ingredient packaged i... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Flurbiprofen active pharmaceutical ingredient packaged in varying grams or kg... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Cisplatin active pharmaceutical ingredient packaged in varying grams or kg in... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.