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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 Pharma Chlorthalidone Tablets Recalled for Potential Metal Contamination

Agency Publication Date: February 15, 2022
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Summary

Sun Pharmaceutical Industries Inc. has recalled 59,232 bottles of Chlorthalidone (25 mg) tablets, a prescription medication used to treat high blood pressure. The recall was initiated because the tablets may contain microscopic stainless steel particles mixed with lubricant oil and silicone particles from manufacturing equipment. No injuries or adverse incidents have been reported to date.

Risk

Ingesting foreign materials like stainless steel or silicone particles can cause internal irritation or other health complications. If you have taken this medication and have concerns, you should contact your doctor or pharmacist immediately.

What You Should Do

  1. This recall affects Sun Pharma Chlorthalidone Tablets USP 25 mg (100-count bottles) with NDC 57664-648-88.
  2. Identify your medication by checking the bottle for lot number P0602 with an expiration date of 03/2023.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Chlorthalidone Tablets USP 25 mg (100-count bottle)
Variants: 25 mg, Tablet
Lot Numbers:
P0602 (Exp 03/2023)
NDC:
57664-648-88

Quantity: 59,232 bottles. Manufactured by Fontida Bio Pharm Inc. in Philadelphia, PA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89529
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: pharmacies nationwide
Manufactured In: United States
Units Affected: 59,232 bottles
Distributed To: Nationwide
Agency Last Updated: February 23, 2022

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.