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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 Amphotericin B Liposome Recalled for Subpotency

Agency Publication Date: June 29, 2023
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Summary

Sun Pharmaceutical Industries Inc. is recalling 12,960 vials of Amphotericin B Liposome for Injection (50mg per vial). This medication, used to treat serious fungal infections, was found to be subpotent, which means it may not contain the full amount of medicine needed to be effective. No incidents or injuries have been reported to date regarding this recall.

Risk

If a patient receives a subpotent dose of this antifungal medication, the treatment may fail to control their serious fungal infection, potentially leading to a worsening of their medical condition.

What You Should Do

  1. This recall affects Amphotericin B Liposome for Injection, 50mg/vial, packaged in single vials (NDC 62756-0233-01) manufactured by Sun Pharmaceutical Medicare Limited.
  2. Identify if you have the affected lots by checking the carton or vial label for lot numbers BAD0089A (Expiration 01/2025) or BAD0330A (Expiration 07/2025).
  3. Stop using the recalled product immediately.
  4. Contact Sun Pharmaceutical Industries Inc. or your distributor to arrange for the return of any remaining vials.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Amphotericin B Liposome for Injection (50mg/vial)
Variants: 50mg/vial, Rx only
Lot Numbers:
BAD0089A (Exp 01/2025)
BAD0330A (Exp 07/2025)
NDC:
62756-0233-01

Quantity: 12,960 vials; Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512; Manufactured by Sun Pharmaceutical Medicare Limited, Gujarat, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92425
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Sun Pharmaceutical Industries, Inc.
Manufactured In: India, United States
Units Affected: 12960 vials
Distributed To: Nationwide

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.