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. Rx-only medication sold in 100-tablet bottles with NDC 29033-056-01.
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 750mg Metformin Hydrochloride Extended-Release Tablets because they contain N-Nitrosodimethylamine (NDMA) impurities above safe levels. This impurity could pose health risks with long-term use, though the recall does not specify immediate danger. Read more at govinfonow.com/recall/36558-nostrum-laboratories-metformin-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36558-nostrum-laboratories-metformin-tablets-recall-ndma-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0227-2021
Cite this page
“Nostrum Laboratories Metformin Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36558-nostrum-laboratories-metformin-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-0227-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0227-2021%22&limit=1).
Why it’s dangerous
The tablets contain N-Nitrosodimethylamine (NDMA) impurities at levels above the acceptable intake limit. While NDMA is a potential carcinogen, the recall indicates this impurity level is not immediately dangerous but could pose health risks with long-term use of the medication.
Who’s affected
Prescription medication users who have the 750mg Metformin Hydrochloride Extended-Release Tablets (100 tablets per bottle) with NDC 29033-056-01. People with diabetes who require 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. These were sold under the brand name 'Nostrum Laboratories' starting in July 2022.
- Brand
Nostrum Laboratories- Category
Drug
What to do — step by step
Check Your Medication
Look for the NDC code 29033-056-01 on the product label to confirm if it's recalled.
Questions people ask
Is this medication safe to use?
The recall states the tablets contain NDMA impurities above safe levels, but the manufacturer does not specify immediate danger. Long-term use could pose health risks.
What should I do if I have this medication?
The recall does not provide specific action steps. Check the NDC code on the label to confirm if it's recalled.
Is there a risk of serious injury from this medication?
The recall does not mention any risk of serious injury or death. The hazard is related to potential long-term health effects from NDMA impurities.
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-0227-2021 — Nostrum Laboratories Nostrum Laboratories Hello, I own a Nostrum Laboratories that is covered by recall D-0227-2021 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-0227-2021 (January 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0227-2021 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.