Browse Drug Recalls
7 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 7 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 7 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 16, 2017 | DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for:... | Failed Impurities/ Degradation Specifications | Class III | Vintage Pharmaceuticals LLC dba Qualitest Pharm... |
| Jul 29, 2015 | Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500... | Failed Dissolution Specifications | Class II | Vintage Pharmaceuticals LLC dba Qualitest Pharm... |
| Dec 6, 2012 | Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged... | Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. | Class I | Vintage Pharmaceuticals LLC DBA Qualitest Pharm... |
| Oct 11, 2012 | Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured f... | Tablet Separation: Possibility of cracked or split coating on the tablets. | Class II | Vintage Pharmaceuticals LLC DBA Qualitest Pharm... |
| Sep 10, 2012 | HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-coun... | Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets result... | Class I | Vintage Pharmaceuticals LLC DBA Qualitest Pharm... |
| Jul 6, 2012 | HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg... | Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month roo... | Class III | Vintage Pharmaceuticals LLC DBA Qualitest Pharm... |
| Jul 6, 2012 | HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bot... | Impurities/Degradation Products: High Out of Specification results for a known impurity resulted ... | Class III | Vintage Pharmaceuticals LLC DBA Qualitest Pharm... |
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.