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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 Hydrochloride Extended Release Tablets Recalled for Rubber Foreign Matter

Agency Publication Date: July 13, 2018
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Summary

Sun Pharmaceutical Industries, Inc. is recalling 2,508 bottles of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, a prescription medication used to control blood sugar levels. This recall was initiated after a piece of a rubber glove was discovered embedded within a single tablet. Consumers should check their prescription bottles immediately to see if they have the affected lot JKT0042A.

Risk

The presence of a foreign object, such as a piece of a rubber glove, in a medication tablet poses a choking hazard and potential gastrointestinal distress if swallowed. While only one tablet was reported to contain foreign matter, the entire lot is being recalled as a precaution to ensure patient safety.

What You Should Do

  1. Check your prescription bottle label to see if you have Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500-count bottle) with NDC 62756-142-02.
  2. Verify if the bottle is from Lot JKT0042A with an expiration date of 1/2021.
  3. If you have the affected medication, contact your healthcare provider or pharmacist for guidance before you stop taking the medication, as suddenly stopping Metformin can impact blood sugar control.
  4. Return any unused product from the affected lot to your pharmacy for a refund and contact Sun Pharmaceutical Industries, Inc. at their Cranbury, NJ location for further instructions.
  5. Report any adverse reactions or quality problems to the FDA Consumer Complaint coordinator at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and medical consultation

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

Affected Products

Product: Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500-count bottle)
Model:
NDC 62756-142-02
Lot Numbers:
JKT0042A (Exp 1/2021)
Date Ranges: Expiration 1/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80440
Status: Resolved
Manufacturer: Sun Pharmaceutical Industries, Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 2508 bottles
Distributed To: Arizona

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 ยท 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.