Browse Drug Recalls
13 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 13 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 13 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 31, 2025 | Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carto... | Failed Stability Specifications: Observed OOS results: eg results for colour index | Class II | Cipla Limited |
| Dec 14, 2018 | Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufa... | Failed Dissolution Specifications. | Class II | Cipla Limited |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 4, 2017 | Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by ... | Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with ill... | Class III | West-Ward Columbus, Inc. |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 1... | Failed dissolution specifications - low dissolution results at S3 stage. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 1... | Failed dissolution specifications - low dissolution results at S3 stage. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 1... | Failed dissolution specifications - low dissolution results at S3 stage. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 1... | Failed dissolution specifications - low dissolution results at S3 stage. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 29, 2016 | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Apr 24, 2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Cipla Limited |
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.