Lovastatin Tablets USP — Class III drug recall D-0513-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-02-27, distributed nationwide. CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for indivi
| Recall number | D-0513-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-02-13 |
| Classified | 2019-02-20 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2020-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 44,640 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0467, 68180-0467-01, 68180-0467-03, 68180-0467-05, 68180-0467-07, 68180-0467-09, 68180-0468, 68180-0468-01, 68180-0468-03, 68180-0468-05, 68180-0468-07, 68180-0468-09, 68180-0469, 68180-0469-01, 68180-0469-03, 68180-0469-05, 68180-0469-07, 68180-0469-09 |
| Expiration dates | 2020-03-20 |
Product
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
Reason for recall
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
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-0513-2019. 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.