Metformin HCL E/R 500 mg — Class II drug recall D-0058-2021
Terminated recall by Direct Rx, reported 2020-11-11, distributed in FL. CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per ma
| Recall number | D-0058-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2020-10-12 |
| Classified | 2020-11-02 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2021-09-22 |
| Distributed | FL |
| Quantity | 88 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 72189-0064, 72189-0064-30, 72189-0064-90, 72189-0150, 72189-0150-30, 72189-0150-90 |
| Lot numbers | 04DE1902, 11DE1908 |
| Expiration dates | 2021-06-30 |
Product
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
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-0058-2021. 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.