PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); 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 HCl ER 500mg tablets due to detected N-Nitrosodimethylamine (NDMA) impurity levels exceeding FDA safety thresholds. This impurity could pose health risks with long-term use, though the recall does not specify immediate harm. Read more at govinfonow.com/recall/37064-pd-rx-metformin-hcl-er-500mg-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37064-pd-rx-metformin-hcl-er-500mg-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1333-2020
Cite this page
“PD-Rx Metformin HCl ER 500mg Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37064-pd-rx-metformin-hcl-er-500mg-recall-ndma-impurity-risk. Based on FDA recall #D-1333-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1333-2020%22&limit=1).
Why it’s dangerous
The recall involves metformin tablets containing N-Nitrosodimethylamine (NDMA), a chemical that can form in some medications. FDA testing found levels of this impurity above the acceptable intake limit, which may pose health risks with long-term use.
Who’s affected
People who have the specific metformin ER 500mg tablets with the listed NDC numbers and expiration dates are affected. Those with diabetes requiring this medication are most at risk.
How to tell if you have this one
Check for metformin HCl ER 500mg tablets with NDC numbers 72789-009-30, 72789-009-60, 72789-009-90, 72789-009-93, or 49483-0623-01. The affected lots have specific expiration dates listed in the recall.
- Brand
PD-Rx- Category
Drug
What to do — step by step
Stop Using Affected Tablets
Discard metformin HCl ER 500mg tablets with the listed NDC numbers and expiration dates as they contain unsafe NDMA levels.
Questions people ask
Why is this medication being recalled?
FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity levels above the acceptable intake limit in these metformin tablets.
What should I do if I have the affected tablets?
Discard the affected metformin tablets immediately and contact your healthcare provider for alternative treatment options.
Are there any specific expiration dates I should check?
Yes, the affected lots have specific expiration dates listed in the recall, such as December 31, 2020, for some batches.
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-1333-2020 — PD-Rx PD-Rx Hello, I own a PD-Rx that is covered by recall D-1333-2020 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-1333-2020 (June 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1333-2020 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.