Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum
Nostrum Laboratories recalls 500mg Metformin ER tablets due to detected N-Nitrosodimethylamine (NDMA) impurity above safe levels. Rx-only bottles with NDC 29033-055-01 may be affected.
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 500mg Metformin Hydrochloride Extended-Release Tablets (Rx-only) 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/36702-nostrum-metformin-500mg-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36702-nostrum-metformin-500mg-tablets-recall-ndma-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0068-2021
Cite this page
“Nostrum Metformin 500mg Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36702-nostrum-metformin-500mg-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-0068-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0068-2021%22&limit=1).
Why it’s dangerous
The tablets contain N-Nitrosodimethylamine (NDMA), a chemical that can form in some medications. While NDMA is present in trace amounts naturally, this recall indicates levels above the acceptable intake limit for long-term use. The impurity may pose health risks with prolonged use, but the recall does not specify immediate harm.
Who’s affected
Prescription patients who have received the specific 500mg Metformin ER tablets with NDC 29033-055-01. 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 500 mg, 100 count bottles' with NDC code 29033-055-01. These were manufactured by Nostrum Laboratories, Inc. in Kansas City, MO and expired by May 2022.
- Brand
Nostrum- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0067-2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01; MET200101, MET200301 EXP 05/2022 | 12,967 bottles |
| D-0068-2021 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01; MET100201, MET100401 EXP 05/2022 | 20,872 bottles |
What to do — step by step
Check Product Details
Look for the NDC code 29033-055-01 on the bottle label to confirm if it's affected.
Questions people ask
Is this product safe to use?
The recall states the product contains NDMA impurities above safe levels, but does not specify immediate danger. Patients should consult their doctor before using.
How can I tell if I have the recalled product?
Check for the NDC code 29033-055-01 on the bottle label. These were manufactured by Nostrum Laboratories, Inc. in Kansas City, MO and expired by May 2022.
What should I do if I have the recalled product?
The recall does not specify a remedy, so patients should contact their doctor for guidance.
Contact Nostrum
We’ve drafted a message you can send Nostrum to request your refund or repair — edit it as you like.
Subject: Recall D-0068-2021 — Nostrum Nostrum Hello, I own a Nostrum that is covered by recall D-0068-2021 from Nostrum. 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-0068-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0068-2021 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.