metFORMIN HCL ER USP 500 mg — Class II drug recall D-1307-2020
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2020-06-24. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake leve
| Recall number | D-1307-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK, United States |
| Recall initiated | 2020-06-05 |
| Classified | 2020-06-12 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2021-11-08 |
| Quantity | 3,703 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 43063-0428-30, 43063-0428-60, 43063-0428-90, 43063-0428-93, 43063-0428-98, 53746-0178-05 |
| Expiration dates | 2020-06-30 |
Product
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Reason for recall
CGMP Deviations: FDA analysis detected 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-1307-2020. 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.