PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC:
PD-Rx Pharmaceuticals recalls metformin ER 500mg tablets with N-Nitrosodimethylamine (NDMA) impurity above safe levels. Consumers should stop using affected lots.
Lower-risk recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Contact the company & request your remedy
What happened, in plain English
PD-Rx Pharmaceuticals is recalling metformin ER 500mg tablets due to unsafe levels of N-Nitrosodimethylamine (NDMA) impurity. This chemical can pose health risks with long-term use, especially for people with diabetes who rely on the medication. Read more at govinfonow.com/recall/37063-pd-rx-metformin-er-500mg-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37063-pd-rx-metformin-er-500mg-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1307-2020
Cite this page
“PD-Rx Metformin ER 500mg Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37063-pd-rx-metformin-er-500mg-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-1307-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1307-2020%22&limit=1).
Why it’s dangerous
The recall is for metformin tablets that contain N-Nitrosodimethylamine (NDMA) impurities above the acceptable safety level. NDMA is a potential carcinogen that can increase cancer risk with long-term exposure, particularly in people taking the medication regularly.
Who’s affected
People with diabetes who take metformin ER 500mg tablets from PD-Rx Pharmaceuticals. Those with diabetes are most at risk due to the medication's role in blood sugar management.
How to tell if you have this one
Check for the product name 'metFORMIN HCL ER USP 500 mg' with NDC codes 43063-428-30, 43063-428-60, 43063-428-90, 43063-428-98, 43063-428-93, or 53746-0178-05. The tablets were manufactured in lots with expiration dates of 06/30/2020.
- Brand
PD-Rx- Category
Drug
What to do — step by step
Check Product Details
Identify your metformin tablets by checking the NDC codes listed in the recall notice.
Stop Using Affected Tablets
If you have the recalled tablets, stop using them immediately and contact PD-Rx for instructions.
Questions people ask
Why is this medication being recalled?
The FDA detected N-Nitrosodimethylamine (NDMA) impurities above the acceptable intake level in these metformin tablets.
What should I do if I have the recalled tablets?
Stop using the affected tablets and contact PD-Rx Pharmaceuticals for instructions on returning them.
Are there any health risks from using these tablets?
Long-term use of metformin with NDMA impurities may increase cancer risk, though the risk is generally low for most users.
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-1307-2020 — PD-Rx PD-Rx Hello, I own a PD-Rx that is covered by recall D-1307-2020 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.
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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-1307-2020 (June 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1307-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.