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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SUN PHARMACEUTICAL INDUSTRIES INC: Metformin HCl Extended-Release Tablets Recalled for Foreign Substance

Agency Publication Date: May 7, 2021
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Summary

Sun Pharmaceutical Industries Inc. is recalling 50,868 bottles of Metformin HCl Extended-Release Tablets (500 mg) because the tablets may contain a foreign substance identified as activated carbon. This prescription medication is used to control blood sugar levels in patients with type 2 diabetes. Consumers should check their 500-count bottles for the specific lot numbers and expiration dates included in this recall. Because this is a prescription medication, you should consult with your healthcare provider or pharmacist for guidance before stopping the medication or seeking a replacement.

Risk

The presence of activated carbon, a foreign substance not intended to be in the medication, can affect the purity and quality of the tablets. While activated carbon is sometimes used medically, its unauthorized presence in this medication poses a moderate risk of unintended side effects or reduced treatment efficacy.

What You Should Do

  1. Check your Metformin HCl Extended-Release Tablets (500 mg) 500-count bottle for NDC 62756-142-02.
  2. Identify if your bottle is from one of the affected lots: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A, JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A, or JKX3224A with an expiration date of 6/2032.
  3. Also check for lot numbers JKX3211A or JKX3212A with an expiration date of 7/2023.
  4. Contact your healthcare provider or pharmacist immediately for guidance and to obtain a replacement prescription before you stop taking the medication.
  5. Return any unused product from the affected lots to your pharmacy for a refund and contact Sun Pharmaceutical Industries Inc. for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Metformin HCl Extended-Release Tablets, USP, 500 mg (500-count bottle)
Model:
NDC 62756-142-02
Lot Numbers:
JKX2749A (Exp 6/2032)
JKX2803A (Exp 6/2032)
JKX2804A (Exp 6/2032)
JKX2805A (Exp 6/2032)
JKX806A (Exp 6/2032)
JKX2945A (Exp 6/2032)
JKX2946A (Exp 6/2032)
JXK2947A (Exp 6/2032)
JKX2948A (Exp 6/2032)
JKX2952A (Exp 6/2032)
JKX2953A (Exp 6/2032)
JKX2954A (Exp 6/2032)
JKX3224A (Exp 6/2032)
JKX3211A (Exp 7/2023)
JKX3212A (Exp 7/2023)
Date Ranges: Exp 6/2032, Exp 7/2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87869
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 50868 bottles
Distributed To: Nationwide
Agency Last Updated: May 27, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.