metformin HCL ER 500 mg — Class II drug recall D-0059-2021
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2020-11-11, distributed in AK, AZ, CA, CO, FL, GA, ID, IL…. CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per ma
| Recall number | D-0059-2021 |
|---|---|
| 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 | 2020-10-06 |
| Classified | 2020-11-02 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2021-10-22 |
| Distributed | AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI |
| Quantity | 1,683 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 72789-0009, 72789-0009-30, 72789-0009-60, 72789-0009-90, 72789-0009-93 |
| Expiration dates | 2021-07-31, 2021-12-31, 2022-04-30 |
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 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
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-0059-2021. 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.