Ezetimibe and Simvastatin Tablets — Class III drug recall D-0462-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-06-18, distributed nationwide. Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhyd
| Recall number | D-0462-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-05-19 |
| Classified | 2025-06-10 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68462-0321, 68462-0321-10, 68462-0321-30, 68462-0321-90, 68462-0322, 68462-0322-10, 68462-0322-30, 68462-0322-90, 68462-0323, 68462-0323-05, 68462-0323-30, 68462-0323-90, 68462-0324, 68462-0324-05, 68462-0324-30, 68462-0324-90 |
| Lot numbers | 17240195 |
| Expiration dates | 2026-01-31 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0462-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.