FDA Drug recall D-0462-2025
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2…
- FDA Drug
- Class III
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class III recall of Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2… by Glenmark Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0462-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-05-19 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Reason
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Identifiers
| ndc | 68462-321-90 |
|---|---|
| ndc | 68462-321-10 |
| ndc | 68462-321-30 |
| ndc | 68462-322-30 |
| ndc | 68462-322-90 |
| ndc | 68462-322-10 |
| ndc | 68462-323-30 |
| ndc | 68462-323-90 |
| ndc | 68462-323-05 |
| ndc | 68462-324-30 |
| ndc | 68462-324-90 |
| ndc | 68462-324-05 |
| code_info | Lot #: 17240195, Exp 01/31/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0462-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.