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Drug recall · FDA · Published May 4, 2021

SUN PHARMACEUTICAL INDUSTRIES INC recalls Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun

Sun Pharmaceutical recalls 500-count Metformin HCl Extended-Release Tablets (500 mg) due to activated carbon contamination. Affected lots expire 6/2032 or 7/2023. Stop using immediately if you have these specific lots.

🇺🇸 FDA recall #D-0372-2021DrugSun Pharmaceutical ›
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Contact the company & request your remedy

Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC2 Independence Way · Princeton, NJ 08540-6620
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sun Pharmaceutical is recalling 500-count bottles of Metformin HCl Extended-Release Tablets (500 mg) because they contain activated carbon. This foreign substance could cause harm if taken, so affected users should stop using the product immediately. Read more at govinfonow.com/recall/36157-sun-pharmaceutical-metformin-tablets-recall-foreign-activated-carbon-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/36157-sun-pharmaceutical-metformin-tablets-recall-foreign-activated-carbon-hazard · Updated October 4, 2026 · FDA enforcement record: FDA #D-0372-2021

Cite this page

“Sun Pharmaceutical Metformin Tablets Recall: Foreign Activated Carbon Hazard.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36157-sun-pharmaceutical-metformin-tablets-recall-foreign-activated-carbon-hazard. Based on FDA recall #D-0372-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0372-2021%22&limit=1).

Why it’s dangerous

The tablets contain activated carbon, a foreign substance that could be harmful if ingested. This contamination may cause adverse health effects, including potential injury from the foreign material entering the body.

Who’s affected

People with prescriptions for Metformin HCl Extended-Release Tablets (500 mg) in 500-count bottles. Those who have the specific lots listed in the recall are most at risk.

How to tell if you have this one

Check your Metformin HCl Extended-Release Tablets (500 mg) packaging for the lot numbers listed: JKX2749A through JKX3224A (expiring 6/2032) or JKX3211A through JKX3212A (expiring 7/2023).

  • Brand
    Sun Pharmaceutical
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    If you have the recalled lots, stop using the Metformin HCl Extended-Release Tablets (500 mg) right away.

✎ GovInfoNow

Questions people ask

Why is activated carbon dangerous in Metformin tablets?

The recall states that activated carbon is a foreign substance present in the tablets, which could cause harm if ingested. The exact health risk isn't specified, but the presence of foreign material is hazardous.

Which lots are affected?

The affected lots are JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A, JKX2946A, JKX2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A, JKX3224A (expiring 6/2032) and JKX3211A, JKX3212A (expiring 7/2023).

How can I check if my tablets are recalled?

Check the lot numbers on your Metformin HCl Extended-Release Tablets (500 mg) packaging. If your lot number matches the affected lots listed in the recall, stop using them immediately.

Take action

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-0372-2021 — Sun Pharmaceutical Sun Pharmaceutical

Hello,

I own a Sun Pharmaceutical that is covered by recall D-0372-2021 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-0372-2021 (May 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0372-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA