Browse Drug Recalls

2,165 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,165 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 2,165 FDA drug recalls.

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DateProductReasonClassFirm
Dec 17, 2014 Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Addit... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dex... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g,... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Tranexamic Acid 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 Famotidine 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 D-Cycloserine 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 Avanafil 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 Neostigmine Methylsulfate 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 Cilostazol 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

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.