Metformin Hydrochloride Extended-Release Tablets USP 1000 mg — Class II drug recall D-1385-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2020-07-22, distributed nationwide. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake leve
| Recall number | D-1385-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2020-07-07 |
| Classified | 2020-07-14 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2021-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 273,060 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 68180-0337-07 |
| Lot numbers | AUG-20, DEC-20, G001763, G001764, G001765, G001766, G001767, G001795, G001836, G001837, G001860, G001861, G001905, G001933, G001934, G807312, G807313, G807314, G807315, G807316, G807325, G807348, G807349, G807350, G807444, G807445, G807507, G807508, G807616, G807617, G807618, G807619, G807620, G807733, G807734, G807735, G808042, G808043, G808373, G808374 and 58 more |
Product
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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-1385-2020. 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.