Amphotericin B Liposome for Injection recall
FDA recall D-0493-2024 · initiated Apr 19, 2024
SUN PHARMACEUTICAL INDUSTRIES INC recalled Amphotericin B Liposome for Injection in Apr 2024 — an FDA Class II recall (D-0493-2024) because Out of specification for assay.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Out of specification for assay
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 11,016 vials
Details
- Product
- 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
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Apr 19, 2024
- FDA report date
- May 15, 2024
Frequently asked
- Was Amphotericin B Liposome for Injection recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Amphotericin B Liposome for Injection in Apr 2024 — an FDA Class II recall (D-0493-2024) because Out of specification for assay. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Amphotericin B Liposome for Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0493-2024 was: Out of specification for assay
- Is a recalled Amphotericin B Liposome for Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Amphotericin B Liposome for Injection are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0493-2024.