Abelcet Injectable Drug Recalled Due to Bacterial Contamination
A sterile injectable drug, Abelcet, is being recalled due to bacterial contamination detected in a nationwide shipment. The recall affects 31,879 vials with lot number 1203A.
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 recall is rated High because it involves a risk-of-harm product (injectable medication) with documented bacterial contamination but no reported illnesses or injuries at the time of recall. The FDA classified it as Class II.
Plain-English summary
Leadiant Biosciences, Inc. is recalling Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL vials distributed nationwide due to a sterility assurance failure. The affected lot is 1203A, which expires May 11, 2024.
Testing revealed the presence of Cupriavidus pauculus bacteria in the product. This bacterial contamination in an injectable medication poses a risk of infection if administered.
The recall affects 31,879 vials that were distributed nationwide. Healthcare providers and dispensers who have received this lot should stop dispensing and quarantine remaining vials. Patients who may have received an injection from this lot should contact their healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Leadiant Biosciences, Inc.
- Category
- Drug
- Affected units
- 31,879
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 (2)
- Lot#: 1203A
- Exp. 5/11/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Leadiant Biosciences, Inc.
See all →- ModerateLeadiant Recalls Subpotent Cystaran Ophthalmic Solution
FDA (Drugs) · 2020-10-21
- ModerateLeadiant Recalls Subpotent Cystaran Ophthalmic Solution
FDA (Drugs) · 2018-04-25
- ModerateLeadiant Recalls Subpotent Cystaran Cysteamine Ophthalmic Solution
FDA (Drugs) · 2018-03-07
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08
Similar recalls
- HighGilead Recalls AmBisome Injection Due to Potential Sterility Assurance Issues
FDA (Drugs) · 2013-07-31
- SevereAstellas Recalls AmBisome Injection Lots Due to Sterility Concerns
FDA (Drugs) · 2013-07-31
- SevereHaloperidol Decanoate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2025-04-30
- SevereHaloperidol Decanoate Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2025-04-16
- SevereHaloperidol Decanoate Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2025-04-30
- HighPyridoxine Injection Solution Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-10-02