Browse Drug Recalls
1,710 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,710 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 1,710 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2012 | Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution,... | Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. | Class III | Ranbaxy Inc. |
| Mar 9, 2012 | Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufact... | Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is... | Class III | Pack Pharmaceuticals |
| Jun 15, 2011 | Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metere... | CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. | Class III | Apotex Corp. |
| May 23, 2011 | Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: ... | Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tab... | Class III | Physicians Total Care, Inc. |
| Apr 8, 2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count table... | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Spe... | Class III | Physicians Total Care, Inc. |
| Apr 8, 2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets ... | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Spe... | Class III | Physicians Total Care, Inc. |
| Apr 8, 2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets ... | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Spe... | Class III | Physicians Total Care, Inc. |
| Feb 10, 2011 | Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), ... | Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (782... | Class III | Abc Compounding Company Inc |
| Feb 8, 2011 | Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by B... | Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA). | Class III | Physicians Total Care, Inc. |
| Jan 19, 2011 | METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only... | Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," inste... | Class III | VistaPharm, 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.