SUN PHARMACEUTICAL INDUSTRIES INC recalls RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx
Sun Pharmaceuticals recalls RIOMET ER metformin due to detected N-nitrosodimethylamine (NDMA) impurity in finished product. This impurity may pose health risks with long-term use. Consumers should contact the manufacturer for details.
Lower-risk recall
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
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What happened, in plain English
Sun Pharmaceuticals is recalling RIOMET ER metformin (500 mg per 5 mL, 16 oz) because it contains an impurity called NDMA. This impurity could potentially cause health risks with long-term use, so affected consumers should stop using the product and contact the manufacturer. Read more at govinfonow.com/recall/36767-sun-pharmaceuticals-riomet-er-metformin-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36767-sun-pharmaceuticals-riomet-er-metformin-recall-ndma-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0002-2021
Cite this page
“Sun Pharmaceuticals RIOMET ER Metformin Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36767-sun-pharmaceuticals-riomet-er-metformin-recall-ndma-impurity-risk. Based on FDA recall #D-0002-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0002-2021%22&limit=1).
Why it’s dangerous
The product contains N-nitrosodimethylamine (NDMA), a chemical that can form in some medications. While NDMA is not typically harmful in small amounts, long-term exposure to higher levels may pose health risks. This impurity was detected during manufacturing and is not expected to cause immediate harm.
Who’s affected
People who have the specific RIOMET ER metformin product with NDC 10631-019-1: 16 oz, 500 mg per 5 mL. Those with diabetes who take this medication are most at risk.
How to tell if you have this one
Check for the product name 'RIOMET ER', strength of 500 mg per 5 mL, and the NDC code 10631-019-17. The product was manufactured with lot number AB06381 and expired October 2021.
- Brand
Sun Pharmaceuticals- Category
Drug
What to do — step by step
Stop Using Product
Immediately stop using the recalled RIOMET ER metformin product if you have it.
Questions people ask
Is this product safe to use?
The product contains a detected impurity (NDMA) that may pose health risks with long-term use, so it is not recommended for continued use.
How can I check if I have the recalled product?
Check for the product name 'RIOMET ER', strength of 500 mg per 5 mL, and the NDC code 10631-019-17 on the label.
What should I do if I have the recalled product?
Stop using the product immediately and contact Sun Pharmaceuticals for further instructions.
Contact Sun Pharmaceuticals
We’ve drafted a message you can send Sun Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0002-2021 — Sun Pharmaceuticals Sun Pharmaceuticals Hello, I own a Sun Pharmaceuticals that is covered by recall D-0002-2021 from Sun 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-0002-2021 (September 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0002-2021 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.