Metformin hydrochloride Extended-Release Tablets — Class II drug recall D-0441-2023
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2023-03-15, distributed in CA. CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Li
| Recall number | D-0441-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2023-02-22 |
| Classified | 2023-03-07 |
| Reported by FDA | 2023-03-15 |
| Terminated | 2023-12-06 |
| Distributed | CA |
| Quantity | 12,044 bottles |
| Reason classes | chemical contamination, cgmp |
| NDC | 00591-2720-60 |
| Lot numbers | 1410946A |
| Expiration dates | 2023-06 |
Product
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
Reason for recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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-0441-2023. 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.