Browse Drug Recalls
2,138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,138 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 2,138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Oct 24, 2014 | Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactur... | Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thick... | Class II | Hospira Inc. |
| Oct 3, 2014 | CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocain... | Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tes... | Class II | Wisconsin Pharmacal Company |
| Sep 17, 2014 | Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manu... | Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamin... | Class II | Janssen Ortho L.L.C. |
| Aug 27, 2014 | Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915... | Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages test... | Class II | Sage Products Inc |
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.