SUN PHARMACEUTICAL INDUSTRIES INC recalls Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun
Sun Pharmaceutical recalls 500-count Metformin HCl Extended-Release Tablets due to failed moisture limits. This could affect product stability and safety for patients using prescription diabetes medication.
Lower-risk recall
Failed Moisture Limits: Out of specification for water content
Contact the company & request your remedy
What happened, in plain English
Sun Pharmaceutical is recalling 500-count Metformin HCl Extended-Release Tablets because they failed moisture limits. This could affect the medication's stability and safety for patients using prescription diabetes medication. Read more at govinfonow.com/recall/36246-sun-pharmaceutical-metformin-tablets-recall-failed-moisture-limits.
Source Summary by GovInfoNow · govinfonow.com/recall/36246-sun-pharmaceutical-metformin-tablets-recall-failed-moisture-limits · Updated October 4, 2026 · FDA enforcement record: FDA #D-0325-2021
Cite this page
“Sun Pharmaceutical Metformin Tablets Recall: Failed Moisture Limits.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36246-sun-pharmaceutical-metformin-tablets-recall-failed-moisture-limits. Based on FDA recall #D-0325-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0325-2021%22&limit=1).
Why it’s dangerous
The tablets failed moisture limits, meaning they may have absorbed too much moisture. This could potentially affect the medication's stability and safety, though the exact risk level is not specified in the recall.
Who’s affected
Patients prescribed Metformin HCl Extended-Release Tablets by a doctor. Those with diabetes who have been using this specific product are most at risk.
How to tell if you have this one
Check for the 500-count bottle labeled 'Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only'. The product was distributed by Sun Pharmaceutical Industries, Inc. and manufactured in India with NDC 62756-142-02.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the 500-count bottle with the NDC code 62756-142-02 and lot number JKU4639A.
Questions people ask
Is this product safe to use?
The recall states the product failed moisture limits, which could affect stability and safety, but the exact risk level is not specified.
How do I know if I have the recalled product?
Check for the 500-count bottle labeled 'Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only' with NDC 62756-142-02 and lot number JKU4639A.
What should I do if I have this product?
The recall does not specify a remedy, so contact your doctor or pharmacist for advice.
Contact Sun Pharmaceutical
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0325-2021 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0325-2021 from Sun Pharmaceutical. 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-0325-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0325-2021 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.