Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Amphotericin B Liposome for Injection Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to Out of specification for assay

Date: April 19, 2024
Company: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SUN PHARMACEUTICAL INDUSTRIES INC directly.

Affected Products

Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01

Quantity: 11,016 vials

Why Was This Recalled?

Out of specification for assay

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report