Prescription antifungal injection product recalled for out-of-specification assay
Sun Pharmaceutical is recalling Amphotericin B for Injection (50 mg vials) due to out-of-specification assay results. The recall affects 11,016 vials with lot numbers BAE0055A, BAE0056A, and BAE0068A distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for out-of-specification assay on an intravenous antifungal medication. No illnesses or injuries are reported in the source. This is a risk-of-harm product where injury has not yet been reported, fitting the rubric criterion for High severity.
Plain-English summary
Sun Pharmaceutical Industries is recalling Amphotericin B for Injection, 50 mg vials, due to test results showing the product does not meet required assay specifications. The affected lot numbers are BAE0055A, BAE0056A, and BAE0068A, all expiring March 2026. Approximately 11,016 vials have been distributed nationwide.
Amphotericin B is a prescription antifungal medication administered intravenously to treat serious fungal infections. An out-of-specification assay means the drug does not meet established standards for potency and purity, and therefore its safety and effectiveness cannot be assured.
This recall affects healthcare facilities and pharmacies that received these specific lot numbers. Healthcare providers should immediately locate and segregate affected vials. Patients currently receiving Amphotericin B from these lots should consult their healthcare provider about their treatment status.
Healthcare facilities and pharmacies should stop using all vials from the affected lots and contact their supplier regarding return or replacement of the recalled product.
The recalled product
- Product
- AMPHOTERICIN B (AMPHOTERICIN B)
- Brand
- AMPHOTERICIN B
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable Antifungal
- Hazard
- Affected units
- 11,016
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: BAE0055A
- BAE0056A
- BAE0068A
- Exp. Date 03/2026
UPCs (1)
- 0362756233010
Distribution
Distributed nationwide across the United States.
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