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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 Potency Issues

Agency Publication Date: May 8, 2024
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Summary

Sun Pharmaceutical Industries Inc. is recalling 11,016 vials of Amphotericin B Liposome for Injection (50mg), a medication used to treat serious fungal infections. The recall was issued because testing showed the medication was "out of specification for assay," meaning the drug's potency or concentration may not be accurate. The affected medication was manufactured by Sun Pharmaceutical Medicare Limited in India and distributed across the United States.

Risk

If a medication's concentration is incorrect, patients may receive more or less of the drug than intended. This could lead to ineffective treatment of a serious infection or potential toxicity from a higher-than-expected dose.

What You Should Do

  1. The recalled product is Amphotericin B Liposome for Injection (50mg vials) with NDC 62756-233-01, distributed by Sun Pharmaceutical Industries, Inc.
  2. Identify if your product is affected by checking the carton or vial for lot numbers BAE0055A, BAE0056A, or BAE0068A with an expiration date of 03/2026.
  3. Stop using the recalled product immediately.
  4. Contact Sun Pharmaceutical Industries Inc or your medical distributor to arrange for the return of any unused vials.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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 vials)
Variants: 50mg, Vials
Lot Numbers:
BAE0055A (Exp 03/2026)
BAE0056A (Exp 03/2026)
BAE0068A (Exp 03/2026)
NDC:
62756-233-01

Quantity: 11,016 vials. Manufactured by Sun Pharmaceutical Medicare Limited, Gujarat, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94442
Status: Active
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Hospitals; Infusion Centers; Wholesale Distributors
Manufactured In: India
Units Affected: 11,016 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.