RemedyRepack Inc. recalls Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc.,
RemedyRepack recalls Metformin Hydrochloride Extended Release 750mg blister packs due to detected N-Nitrosodimethylamine (NDMA) impurity above safe levels. This may pose health risks with long-term use.
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
RemedyRepack has recalled Metformin Hydrochloride Extended Release 750 mg tablets because they contain unsafe levels of N-Nitrosodimethylamine (NDMA). This impurity could pose health risks with long-term use of the medication. Read more at govinfonow.com/recall/36709-remedyrepack-metformin-extended-release-750mg-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36709-remedyrepack-metformin-extended-release-750mg-recall-ndma-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0050-2021
Cite this page
“RemedyRepack Metformin Extended Release 750mg Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36709-remedyrepack-metformin-extended-release-750mg-recall-ndma-impurity-risk. Based on FDA recall #D-0050-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0050-2021%22&limit=1).
Why it’s dangerous
The medication contains N-Nitrosodimethylamine (NDMA) impurity at levels above what's considered safe. This impurity has been detected in the product during manufacturing and could pose health risks with long-term use.
Who’s affected
People who have the specific Metformin Hydrochloride Extended Release 750 mg blister packs with the listed lot numbers and expiration dates are affected. Those taking this medication for diabetes management are most at risk.
How to tell if you have this one
Check for Metformin Hydrochloride Extended Release 750 mg, 30-count blister packs with lot numbers J0423350-121219 through J0472532-081020 and expiration dates from 12/31/2020 to 08/31/2021.
- Brand
RemedyRepack- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the blister pack to confirm if it's in the recalled range.
Questions people ask
Is this product safe to use?
The product contains NDMA impurity above safe levels, so it is not recommended for use. The manufacturer has recalled it.
What should I do if I have this product?
Check the product details to see if it's in the recalled range. If it is, contact the manufacturer for instructions.
How can I get a replacement?
The recall record does not specify a replacement process or remedy.
Contact RemedyRepack
We’ve drafted a message you can send RemedyRepack to request your refund or repair — edit it as you like.
Subject: Recall D-0050-2021 — RemedyRepack RemedyRepack Hello, I own a RemedyRepack that is covered by recall D-0050-2021 from RemedyRepack. 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-0050-2021 (October 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0050-2021 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.