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Browse Drug Recalls

61 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 61 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 61 FDA drug recalls.

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DateProductReasonClassFirm
Aug 22, 2017 Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-... Crystallization: Product is being recalled due to the manufacturer's recall due to the presence o... Class II RemedyRepack Inc.
Feb 7, 2017 Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsi... Failed Dissolution Specifications Class II RemedyRepack Inc.
Nov 11, 2015 Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Ind... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, ... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutiona... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Ba... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, R... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Instituti... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma In... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Apr 23, 2015 KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside ... Crystallization Class II RemedyRepack Inc.
Feb 18, 2015 KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside... Crystallization Class II RemedyRepack 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.