PD-Rx Pharmaceuticals, Inc. recalls metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC:
PD-Rx Pharmaceuticals recalls metformin HCl ER 750mg tablets with N-Nitrosodimethylamine (NDMA) impurity above safe levels. Affected lots expire through March 2022. Consumers should stop using and contact for return.
Lower-risk recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Contact the company & request your remedy
What happened, in plain English
PD-Rx Pharmaceuticals is recalling metformin HCl ER 750mg tablets due to detected N-Nitrosodimethylamine (NDMA) impurities exceeding safe limits. This impurity could pose health risks with long-term use. The recall affects specific lots manufactured between 2020 and 2021. Read more at govinfonow.com/recall/36735-pd-rx-metformin-er-750mg-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36735-pd-rx-metformin-er-750mg-recall-ndma-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0060-2021
Cite this page
“PD-Rx Metformin ER 750mg Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36735-pd-rx-metformin-er-750mg-recall-ndma-impurity-risk. Based on FDA recall #D-0060-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0060-2021%22&limit=1).
Why it’s dangerous
NDMA is a potential carcinogen that can form in some medications during manufacturing. The impurity levels in these metformin tablets exceed the acceptable intake limit set by the manufacturer, which could lead to health risks with long-term use.
Who’s affected
People with prescriptions for metformin HCl ER 750mg tablets from PD-Rx Pharmaceuticals. Those with specific lots and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check for the product name 'metformin HCL ER 750 mg Rx only' with NDC numbers 43063-902-30 or 43063-902-60. The affected lots have specific expiration dates through March 2022.
- Brand
PD-Rx- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0059-2021 | 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; Lots: a) B20D23, B20D67 Exp. 07/31/21, C20D55 Exp. 12/31/21; b) A20D92, A20F59, B20C16 Exp. 07/31/21, C20D63, D20A45, D20C80 Exp. 12/31/21, G20D46, I20C57 Exp. 04/30/22; c) A20D90, A20E77, A20F69, B20F43 Exp. 07/31/21, C20B14, D20A41 Exp. 12/31/21, I20D94, I20E56, J20A28 Exp. 04/30/22; d) B20B96 Exp. 07/31/21, C20C28, C20E58, D20B17 Exp. 12/31/21, G20D91 Exp. 04/30/22 | 1683 bottles | 72789-009-30, 72789-009-60, 72789-009-90, 72789-009-93 |
| D-0060-2021 | 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; Lots: a) A20A97, B20D25 Exp. 04/30/21, B20D69, C20B95, C20D60, E20A50 Exp. 07/31/21, E20D37, E20D73 Exp. 03/31/22, J19F04 Exp. 01/31/21; b) C20C15 Exp. 07/31/21, F20A14 Exp. 03/31/22, L19C15 Exp. 04/30/21 | 125 bottles | 43063-902-30, 43063-902-60 |
What to do — step by step
Stop Using Tablets
Immediately stop using the recalled metformin HCl ER 750mg tablets if you have them.
Contact PD-Rx
Contact PD-Rx Pharmaceuticals for a return or exchange of the affected tablets.
Questions people ask
What is the specific impurity in the recalled metformin?
The recall involves N-Nitrosodimethylamine (NDMA) impurities detected above the acceptable intake level.
Which lots of metformin are affected?
Affected lots include specific batches with expiration dates through March 2022, as listed in the recall notice.
How can I check if my metformin is recalled?
Check the NDC numbers (43063-902-30 or 43063-902-60) and expiration dates against the list provided in the recall.
Contact PD-Rx
We’ve drafted a message you can send PD-Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0060-2021 — PD-Rx PD-Rx Hello, I own a PD-Rx that is covered by recall D-0060-2021 from PD-Rx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0060-2021 (October 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0060-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.