Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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DateProductReasonClassFirm
Dec 4, 2014 Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-c... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Dec 4, 2014 Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline H... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: M... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Dec 4, 2014 Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the C... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (1... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, ... Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue ... Class I Baxter Healthcare Corp
Dec 3, 2014 Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61... Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cra... Class II Pfizer Inc.
Dec 3, 2014 Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose F... Lack of Assurance of Sterility; improperly crimped fliptop vials Class II Hospira Inc.
Dec 3, 2014 MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake F... Failed Stability Specifications: Product is subpotent and has out of specification known and unkn... Class I Hospira Inc.
Nov 26, 2014 Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured b... Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. Class II Zydus Pharmaceuticals USA Inc
Nov 25, 2014 Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx... Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when st... Class III Hospira Inc.
Nov 25, 2014 Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal Class II Baxter Healthcare Corp.
Nov 24, 2014 HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distr... Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydro... Class II Par Pharmaceutical Inc.
Nov 20, 2014 GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexa... Class II One and Zen
Nov 19, 2014 Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori... Class II American Health Packaging
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

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.