metFORMIN HCL ER 500 mg — Class II drug recall D-1333-2020
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2020-07-01. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake leve
| Recall number | D-1333-2020 |
|---|---|
| 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 | 2020-06-20 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2021-11-08 |
| Quantity | 1,969 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 49483-0623-01, 72789-0009, 72789-0009-30, 72789-0009-60, 72789-0009-90, 72789-0009-93 |
| Expiration dates | 2020-08-21, 2020-12-31 |
Product
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, 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-1333-2020. 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.