metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals… — Class II drug recall D-0060-2021
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-0060-2021 |
|---|---|
| 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 | 125 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 43063-0902, 43063-0902-30, 43063-0902-60 |
| Expiration dates | 2021-01-31, 2021-04-30, 2021-07-31, 2022-03-31 |
Product
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60
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-0060-2021. 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.