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Class II · ModerateActive recall

Amphotericin B

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Out of specification for assay

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India foreign manufacturer
Brand nameAMPHOTERICIN B
Generic nameAMPHOTERICIN B
Active ingredient(s)AMPHOTERICIN B
Distributed by / forSun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
NDC62756-233-01
Show the full FDA record
Full product labelAmphotericin 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
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide within the United States
Quantity11,016 vials
Recall initiated2024-04-19
Report date2024-05-15
Recall completed—
Recall numberD-0493-2024
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.