Metformin Hydrochloride Extended Release 750 mg — Class II drug recall D-0050-2021
Terminated recall by RemedyRepack Inc., reported 2020-11-04. CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per ma
| Recall number | D-0050-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2020-10-11 |
| Classified | 2020-10-26 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2021-02-24 |
| Quantity | 79 |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 70518-2480-00 |
| Lot numbers | J0423350-121219, J0434828-020320, J0442511-031220, J0448429-040920, J0472499-081020, J0472532-081020 |
| Expiration dates | 2020-12-31, 2021-02-28, 2021-03-31, 2021-04-30, 2021-08-31 |
Product
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Reason for recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
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-0050-2021. 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.