Granules Pharmaceuticals Inc recalls Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle
FDA recalls Granules Pharmaceuticals' Metformin Hydrochloride Extended-Release Tablets due to N-Nitrosodimethylamine (NDMA) impurity exceeding safe levels. Affected products include 100-count and 500-count bottles with specific NDC numbers.
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
Granules Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets (750 mg) because the FDA found unsafe levels of N-Nitrosodimethylamine (NDMA) impurity. This impurity could pose health risks with long-term use, though the recall does not specify immediate danger. Read more at govinfonow.com/recall/36960-metformin-750mg-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36960-metformin-750mg-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1386-2020
Cite this page
“Metformin 750mg Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36960-metformin-750mg-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-1386-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1386-2020%22&limit=1).
Why it’s dangerous
The FDA detected N-Nitrosodimethylamine (NDMA) impurity in levels above the acceptable intake limit. This chemical is a known carcinogen, meaning it could increase cancer risk with prolonged exposure. However, the recall does not indicate immediate health threats.
Who’s affected
People who purchased the recalled Metformin Hydrochloride Extended-Release Tablets (750 mg) from the listed NDC numbers. Those with diabetes who take this medication are most at risk due to potential long-term health effects.
How to tell if you have this one
Check for the product name 'Metformin Hydrochloride Extended-Release Tablets USP, 750 mg' in 100-count or 500-count bottles with NDC numbers 70010-492-01 or 70010-492-05. The bottles were manufactured between May 2021 and January 2023.
- Brand
Granules Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC number on the bottle label to confirm if it matches the recalled products (70010-492-01 or 70010-492-05).
Contact Manufacturer
Reach out to Granules Pharmaceuticals for guidance on next steps if you have the recalled product.
Questions people ask
Is this product dangerous to use?
The FDA found unsafe levels of N-Nitrosodimethylamine (NDMA) impurity, which is a potential carcinogen. However, the recall does not indicate immediate health risks, so the risk is considered low for most users.
How can I tell if I have the recalled product?
Look for the product name 'Metformin Hydrochloride Extended-Release Tablets USP, 750 mg' in 100-count or 500-count bottles with NDC numbers 70010-492-01 or 70010-492-05. The bottles were manufactured between May 2021 and January 2023.
What should I do if I have the recalled product?
Contact Granules Pharmaceuticals directly for instructions on how to handle the product. The recall does not specify a return or disposal process.
Contact Granules Pharmaceuticals
We’ve drafted a message you can send Granules Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1386-2020 — Granules Pharmaceuticals Granules Pharmaceuticals Hello, I own a Granules Pharmaceuticals that is covered by recall D-1386-2020 from Granules 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-1386-2020 (July 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1386-2020 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.