Metformin Hydrochloride Extended-release Tablets USP — Class II drug recall D-1334-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2020-07-01, distributed nationwide. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake leve
| Recall number | D-1334-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2020-06-11 |
| Classified | 2020-06-20 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2021-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 6,540 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 68180-0336-07 |
| Lot numbers | G901203 |
| Expiration dates | 2020-12 |
Product
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)
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-1334-2020. 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.