Pravastatin Sodium Tablets — Class II drug recall D-0612-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-07-24, distributed nationwide. Failed Dissolution Specifications: results below specifications
| Recall number | D-0612-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2024-06-28 |
| Classified | 2024-07-18 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68462-0195, 68462-0195-05, 68462-0195-90, 68462-0196, 68462-0196-05, 68462-0196-90, 68462-0197, 68462-0197-05, 68462-0197-90, 68462-0198, 68462-0198-05, 68462-0198-90 |
| Expiration dates | 2024-06-30, 2024-07-31, 2024-10-31, 2025-01-31 |
Product
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Reason for recall
Failed Dissolution Specifications: results below specifications
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-0612-2024. 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.