Metformin Hydrochloride Extended-Release Tablets USP 1000 mg — Class II drug recall D-1383-2020
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-1383-2020 |
|---|---|
| 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 | 95,886 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 68180-0338, 68180-0338-01, 68180-0338-02, 68180-0338-03, 68180-0339, 68180-0339-01, 68180-0339-02, 68180-0339-09 |
| Lot numbers | APR-21, AUG-20, AUG-21, FEB-22, G001801, G001802, G001803, G001804, G001805, G001806, G001807, G001808, G001809, G002563, G002564, G807092, G807093, G807147, G807208, G807479, G807480, G807830, G808074, G808115, G808154, G808155, G809471, G900227, G900228, G900229, G900230, G900231, G900232, G903277, G903278, G903279, G903280, G903281, G903818, G904048 and 16 more |
Product
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09
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-1383-2020. 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.