RecallRadar

FDA Drug recall D-0891-2023

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc

On 2023-07-05 the FDA classified a Class II recall of Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc by Sun Pharmaceutical Industries, citing subpotent drug.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0891-2023
ClassificationClass II
Statusterminated
Initiated2023-05-30
Published2023-07-05
Last updated2026-09-13 11:52 UTC
CompanySun Pharmaceutical Industries
DistributionUS

Product

Amphotericin B Liposome for Injection, 50mg/vial, 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 62756-0233-01

Reason

Subpotent drug

Identifiers

code_infoLot # BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0891-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.