Teva Recalls Metformin ER 1000mg Due to NDMA Contamination
Teva Pharmaceuticals recalls specific lots of Metformin hydrochloride Extended-Release Tablets due to elevated NDMA levels exceeding safety limits.
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CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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What happened, in plain English
Teva Pharmaceuticals USA Inc. is recalling a specific lot of Metformin hydrochloride Extended-Release Tablets, 1000 mg, because testing detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. The product was manufactured by Actavis Laboratories FL, Inc. and distributed by Actavis Pharma, Inc. This recall affects 12,044 bottles distributed in California. Read more at govinfonow.com/recall/33859-teva-recalls-metformin-er-1000mg-due-to-ndma-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/33859-teva-recalls-metformin-er-1000mg-due-to-ndma-contamination · Updated October 10, 2026 · FDA enforcement record: FDA #D-0441-2023
Cite this page
“Teva Recalls Metformin ER 1000mg Due to NDMA Contamination.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/33859-teva-recalls-metformin-er-1000mg-due-to-ndma-contamination. Based on FDA recall #D-0441-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0441-2023%22&limit=1).
Why it’s dangerous
The hazard involves CGMP (Current Good Manufacturing Practice) deviations resulting in the detection of N-Nitrosodimethylamine (NDMA). The levels found exceed the Acceptable Daily Intake Limit, posing a health risk associated with this contaminant.
Who’s affected
Patients in California who have been prescribed or possess the specific lot of Metformin hydrochloride Extended-Release Tablets, 1000 mg, manufactured by Actavis. Individuals taking this medication are at risk due to potential exposure to NDMA levels above safety limits.
How to tell if you have this one
Check your medication bottle for the following details: Product is Metformin hydrochloride Extended-Release Tablets, 1000 mg, in a 60-count bottle. Look for NDC 00591-2720-60 and Lot # 1410946A with an expiration date of 06/2023. The bottle was distributed in California.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Stop taking the medication
Do not consume the recalled Metformin hydrochloride Extended-Release Tablets due to the NDMA contamination risk.
Contact your healthcare provider
Speak with your doctor or pharmacist immediately for guidance on alternative treatments or next steps, as no specific remedy is listed in the record.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0441-2023 (February 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0441-2023 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.