Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by:
Nostrum Laboratories recalls 750mg Metformin Hydrochloride Extended-Release Tablets due to N-Nitrosodimethylamine (NDMA) impurity exceeding safe levels. This prescription medication may pose health risks if taken.
Lower-risk recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Contact the company & request your remedy
What happened, in plain English
Nostrum Laboratories is recalling prescription Metformin Hydrochloride Extended-Release Tablets (750 mg, 100 tablets per bottle) because they contain N-Nitrosodimethylamine (NDMA) impurities above safe levels. This impurity could potentially cause health risks with long-term use of the medication. Read more at govinfonow.com/recall/36544-nostrum-laboratories-metformin-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36544-nostrum-laboratories-metformin-tablets-recall-ndma-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0249-2021
Cite this page
“Nostrum Laboratories Metformin Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36544-nostrum-laboratories-metformin-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-0249-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0249-2021%22&limit=1).
Why it’s dangerous
The medication contains N-Nitrosodimethylamine (NDMA) impurities at levels above what's considered safe. NDMA is a potential carcinogen that could increase cancer risk with long-term exposure. However, the recall is for prescription medication with specific manufacturing details.
Who’s affected
Prescription diabetes medication users who have the specific 750 mg extended-release tablets with NDC 29033-056-01 and lot number MET200601 from July 2022. People with diabetes who take this medication are most at risk.
How to tell if you have this one
Check for the product name 'Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle' with NDC code 29033-056-01 and lot number MET200601 from July 2022. This medication is only available by prescription.
- Brand
Nostrum Laboratories- Category
Drug
What to do — step by step
Check Medication Details
Look for the NDC code 29033-056-01 and lot number MET200601 on the product label.
Questions people ask
Is this medication safe to use?
The recall indicates the medication contains NDMA impurities above safe levels, but the manufacturer has not provided specific instructions on whether it's safe to use. This is a prescription medication that requires medical supervision.
What should I do if I have this medication?
The recall does not specify a remedy, so you should contact your healthcare provider for guidance on whether to continue using the medication or switch to an alternative.
How can I confirm if my medication is recalled?
Check the NDC code 29033-056-01 and lot number MET200601 on the product label. This medication is only available by prescription.
Contact Nostrum Laboratories
We’ve drafted a message you can send Nostrum Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0249-2021 — Nostrum Laboratories Nostrum Laboratories Hello, I own a Nostrum Laboratories that is covered by recall D-0249-2021 from Nostrum Laboratories. 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-0249-2021 (January 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0249-2021 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.