Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-0068-2021
Ongoing recall by Nostrum Laboratories Inc, reported 2020-11-11, distributed nationwide. CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
| Recall number | D-0068-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nostrum Laboratories Inc, Kansas City, MO, United States |
| Recall initiated | 2020-10-23 |
| Classified | 2020-11-05 |
| Reported by FDA | 2020-11-11 |
| Distributed | Nationwide (US) |
| Quantity | 20,872 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 29033-0055-01 |
| Expiration dates | 2022-05 |
Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
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-0068-2021. 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.