Metformin Hydrochloride Extended — Class II drug recall D-1331-2020
Terminated recall by Teva Pharmaceuticals USA, reported 2020-07-01, distributed nationwide. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake leve
| Recall number | D-1331-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2020-06-02 |
| Classified | 2020-06-19 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2024-04-12 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 62037-0571-01, 62037-0571-10 |
| Expiration dates | 2020-06, 2020-10, 2020-11, 2020-12, 2021-09, 2021-11 |
Product
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
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-1331-2020. 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.