Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-1360-2020
Terminated recall by The Harvard Drug Group, reported 2020-07-08, distributed nationwide. CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
| Recall number | D-1360-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2020-06-12 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2022-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,906 cartons |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 00904-5794-61 |
| Lot numbers | T-02134 |
| Expiration dates | 2020-09 |
Product
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61
Reason for recall
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
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-1360-2020. 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.