Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-0249-2021
Ongoing recall by Nostrum Laboratories Inc, reported 2021-02-10, distributed nationwide. CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
| Recall number | D-0249-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nostrum Laboratories Inc, Kansas City, MO, United States |
| Recall initiated | 2021-01-25 |
| Classified | 2021-02-04 |
| Reported by FDA | 2021-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 7,071 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 29033-0056-01 |
| Lot numbers | MET200601 |
Product
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
Reason for recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
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-0249-2021. 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.