Denton Pharma, Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC
Denton Pharma recalls Metformin Hydrochloride Extended-Release Tablets (500mg) due to detected N-Nitrosodimethylamine (NDMA) impurity above safe levels. Affected products include 30-count, 60-count, 90-count, and 120-count bottles with specific NDC numbers and expiration dates.
Lower-risk recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Contact the company & request your remedy
What happened, in plain English
Denton Pharma is recalling Metformin Hydrochloride Extended-Release Tablets (500mg) because they found N-Nitrosodimethylamine (NDMA) impurities at levels above what's considered safe. This impurity could pose a health risk if taken over time, so affected users should stop using the product and contact the manufacturer for instructions. Read more at govinfonow.com/recall/36731-denton-pharma-metformin-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36731-denton-pharma-metformin-tablets-recall-ndma-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0057-2021
Cite this page
“Denton Pharma Metformin Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36731-denton-pharma-metformin-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-0057-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0057-2021%22&limit=1).
Why it’s dangerous
The recall is due to the presence of N-Nitrosodimethylamine (NDMA), a chemical that can form in some medications. When detected at levels above the acceptable intake, it may pose a health risk over time, though the risk is considered low for most users.
Who’s affected
People who have the recalled Metformin Hydrochloride Extended-Release Tablets (500mg) in 30-count, 60-count, 90-count, or 120-count bottles with specific NDC numbers and expiration dates. Those taking this medication for diabetes are most at risk.
How to tell if you have this one
Check for Metformin Hydrochloride Extended-Release Tablets (500mg) in 30-count, 60-count, 90-count, or 120-count bottles with NDC numbers like 70934-309-30, 70934-309-60, 70934-309-90, or 70934-309-98. Also look for expiration dates on the packaging.
- Brand
Denton Pharma- 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
Indiana - Nationwide.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0056-2021 | Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30; N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021 | N/A |
| D-0057-2021 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131; a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021 | a) 684; b) 432; c) 3668; d) 2029 bottles |
What to do — step by step
Stop Using the Product
Immediately stop using the recalled Metformin Hydrochloride Extended-Release Tablets (500mg) if you have them.
Contact Manufacturer
Reach out to Denton Pharma for instructions on how to return the product or get a replacement.
Questions people ask
Is this recall dangerous?
The recall is due to detected N-Nitrosodimethylamine (NDMA) impurities above safe levels, but the risk is considered low for most users. Denton Pharma has not stated that this poses an immediate danger to health.
What products are affected?
The affected products are Metformin Hydrochloride Extended-Release Tablets (500mg) in 30-count, 60-count, 90-count, and 120-count bottles with specific NDC numbers and expiration dates.
How do I know if I have the recalled product?
Check the product label for the NDC numbers: 70934-309-30 (30-count), 70934-309-60 (60-count), 70934-309-90 (90-count), or 70934-309-98 (120-count). Also look for the expiration date on the packaging.
Contact Denton Pharma
We’ve drafted a message you can send Denton Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0057-2021 — Denton Pharma Denton Pharma Hello, I own a Denton Pharma that is covered by recall D-0057-2021 from Denton Pharma. 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-0057-2021 (October 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0057-2021 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.