Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC
Teva Pharmaceuticals USA recalls 500mg Metformin Hydrochloride Extended-Release Tablets due to N-Nitrosodimethylamine (NDMA) impurity exceeding safe levels. Affected products include specific NDC numbers and expiration dates.
Lower-risk recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals USA is recalling 500mg Metformin Hydrochloride Extended-Release Tablets because they contain unsafe levels of N-Nitrosodimethylamine (NDMA). This impurity could pose health risks with long-term use, so affected consumers should stop using the product and contact the manufacturer. Read more at govinfonow.com/recall/37074-teva-metformin-extended-release-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37074-teva-metformin-extended-release-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1331-2020
Cite this page
“Teva Metformin Extended-Release Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37074-teva-metformin-extended-release-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-1331-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1331-2020%22&limit=1).
Why it’s dangerous
The recall is due to FDA findings that the medication contains N-Nitrosodimethylamine (NDMA) impurities at levels above the acceptable intake limit. While NDMA is a potential carcinogen, the risk from this specific impurity in the medication is considered low for most users based on current testing.
Who’s affected
People who have the specific 500mg Metformin Extended-Release Tablets with NDC numbers 62037-571-01 or 62037-571-10. Those 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' and NDC numbers 62037-571-01 (100 tablets) or 62037-571-10 (1,000 tablets). The expiration dates range from June 2020 to November 2021.
- Brand
Teva Pharmaceuticals- 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
Terminated- Distribution
Product was distributed throughout the United States, including Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1331-2020 | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ; a) 1329548A, exp. date 06/2020 1338302M, exp. date 10/2020 1348968M, exp. date 10/2020 1348969M, exp. date 10/2020 1348970M, exp. date 11/2020 1376339M,, exp. date 09/2021 b) 1323460M, exp. date 06/2020 1330919M, exp. date 6/2020 1338300A, exp. date 10/2020 1341135M, exp. date 12/2020 1391828M, exp. date 11/2021 | a) 92,793 bottles and b) 4,824 bottles |
| D-1332-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ; a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021 | a) 15,329 bottles and b) 137 bottles |
What to do — step by step
Stop Using Product
Immediately stop using the recalled Metformin Hydrochloride Extended-Release Tablets if you have them.
Questions people ask
Is this product safe to use?
The FDA found unsafe levels of NDMA impurities in this product, so it is not safe for long-term use. Affected consumers should stop using it and contact Teva.
What is the NDC number for this product?
The NDC numbers are 62037-571-01 (100 tablets) and 62037-571-10 (1,000 tablets).
How do I know if I have the recalled product?
Check the product label for 'Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg' and the specific NDC numbers listed in the recall notice.
Contact Teva Pharmaceuticals
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1331-2020 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-1331-2020 from Teva Pharmaceuticals. 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-1331-2020 (June 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1331-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.