Class II · Moderate risk
Amphotericin B Liposome for Injection
Out of specification for assay
Abelcet (Amphotericin B Lipid Complex)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41
Affected NDC
57665-0101-41
Compare with the code on your package — it is the most precise check available.
Drug: Amphotericin
- Recalling firm
- Leadiant Biosciences, Inc.
- NDC code
- 57665-101-41
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0327-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Amphotericin recalls
See all
Class II · Moderate risk
Amphotericin B Liposome for Injection
Subpotent drug
Class II · Moderate risk
CSF-HC Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
CSF Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
Amphotericin B 0.15% Eye Drops
Lack of sterility assurance.
Other recalls by Leadiant Biosciences, Inc.
All 2023 recalls
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.