Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-0057-2021
Ongoing recall by Denton Pharma, Inc., reported 2020-11-11, distributed nationwide. CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per ma
| Recall number | D-0057-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denton Pharma, Inc., North Blenheim, NY, United States |
| Recall initiated | 2020-10-08 |
| Classified | 2020-11-02 |
| Reported by FDA | 2020-11-11 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 70934-0309-30, 70934-0309-60, 70934-0309-90, 70934-0309-98 |
| Expiration dates | 2020-10-31, 2020-12-31, 2021-06-30, 2021-09-30 |
Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
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-0057-2021. 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.