Metformin Hydrochloride Extended-Release Tablets USP — Class II drug recall D-1386-2020
Ongoing recall by Granules 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-1386-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Granules Pharmaceuticals Inc, Chantilly, VA, United States |
| Recall initiated | 2020-07-03 |
| Classified | 2020-07-14 |
| Reported by FDA | 2020-07-22 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 70010-0491, 70010-0491-01, 70010-0491-05, 70010-0491-09, 70010-0491-10, 70010-0491-18, 70010-0491-19, 70010-0492, 70010-0492-01, 70010-0492-05, 70010-0492-20, 70010-0492-21 |
Product
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India
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-1386-2020. 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.