Metformin 750 mg Extended Release NDC # 70518-2920-00 — Class II drug recall D-0366-2022
Terminated recall by RemedyRepack Inc., reported 2022-01-19. CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Li
| Recall number | D-0366-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2021-12-30 |
| Classified | 2022-01-11 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2022-03-28 |
| Quantity | 56 blister |
| Reason classes | chemical contamination, cgmp |
| NDC | 70518-2920-00 |
| Lot numbers | J0495111-120120, J0496563-120820, J0499451-122220, J0511265-021121 |
| Expiration dates | 2021-12-31, 2022-01-31, 2022-02-28 |
Product
Metformin 750 mg Extended Release NDC # 70518-2920-00
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-0366-2022. 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.