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
Nov 14, 2014 Chloroquine Phosphate active pharmaceutical ingredient packaged in varying gr... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Lisinopril 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 Benztropine Mesylate 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 Histamine Diphosphate active pharmaceutical ingredient packaged in varying gr... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Valacyclovir 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 Rocuronium Bromide 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 Estriol (Ultra-Micronized) active pharmaceutical ingredient packaged in varyi... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Amikacin Sulfate 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 Nitazoxanide 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 Baclofen 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 Acetazolamide 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 Nevirapine 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 Mitotane 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 Magnesium Stearate 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 Gabapentin 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 Paromomycin Sulphate 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 Pancuronium Bromide 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 Mebendazole 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 Pioglitazone 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 Melphalan 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 Levothyroxine Sodium (T4) 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 Lodenafil Carbonate 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 2-Deoxy-D-Glucose 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 Methotrexate Sodium 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 Bovine Insulin 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 Ibuprofen 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 Belladonna Extract Powder 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 Roflumilast 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 Uridine-5'Triphosphate Trisodium Salt active pharmaceutical ingredient packag... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Ethinyl Estradiol 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 Vidarbine Monophosphate active pharmaceutical ingredient packaged in varying ... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 4-Aminopyridine 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 Lidocaine 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 Tolvaptan 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 Diphenylcyclopropenone 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 Methyl Folate Calcium active pharmaceutical ingredient packaged in varying gr... Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... Class II Attix Pharmaceuticals
Nov 14, 2014 Homatropine Methylbromide 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 12, 2014 GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Do... Defective Container: Vials may be missing stoppers. Class II Fresenius Kabi USA, LLC
Nov 10, 2014 Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-releas... Defective container: A customer complaint revealed the presence of a defective seal on the top of... Class III Reckitt Benckiser LLC
Nov 10, 2014 Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose con... Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were inc... Class II Baxter Healthcare Corp.
Nov 7, 2014 Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmac... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Com... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Phar... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding ... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compo... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compoundi... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding P... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g... Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another ... Class III Hospira 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.