Pravastatin Sodium Tablets USP — Class II drug recall D-1120-2019
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2019-04-17, distributed nationwide. Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
| Recall number | D-1120-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2019-03-25 |
| Classified | 2019-04-11 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-09-14 |
| Distributed | Nationwide (US) |
| 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 |
| Lot numbers | 17181491 |
| Expiration dates | 2021-08-20 |
Product
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Reason for recall
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
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-1120-2019. 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.