Abelcet Injection Recall: Risk of Contamination from Cupriavidus pauculus
Leadiant Biosciences recalls Abelcet (Amphotericin B Lipid Complex) injection due to potential contamination with Cupriavidus pauculus. This may cause infection in patients receiving the medication.
Recall notice
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Contact the company
What happened, in plain English
Leadiant Biosciences is recalling Abelcet (Amphotericin B Lipid Complex) injections because they may contain Cupriavidus pauculus, a bacterium that could cause infections. This recall affects patients using the medication under a prescription. Read more at govinfonow.com/recall/33967-abelcet-injection-recall-risk-of-contamination-from-cupriavidus-pauculus.
Source Summary by GovInfoNow · govinfonow.com/recall/33967-abelcet-injection-recall-risk-of-contamination-from-cupriavidus-pauculus · Updated August 18, 2026 · FDA enforcement record: FDA #D-0327-2023
Cite this page
“Abelcet Injection Recall: Risk of Contamination from Cupriavidus pauculus.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33967-abelcet-injection-recall-risk-of-contamination-from-cupriavidus-pauculus. Based on FDA recall #D-0327-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0327-2023%22&limit=1).
Why it’s dangerous
The injection may contain Cupriavidus pauculus, a bacterium that can lead to infections. This contamination risk is specific to the medication's sterility during manufacturing.
Who’s affected
Patients prescribed Abelcet injections by a healthcare provider. Those with compromised immune systems are at higher risk of infection.
How to tell if you have this one
Check for the product name 'Abelcet', strength 5 mg/mL, 100 mg vial, and prescription-only status. The lot number 1203A and expiration date 5/11/2024 are also associated with this recall.
- Brand
Leadiant Biosciences- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, strength, and lot number to confirm if it is part of this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates a potential contamination risk, so it is not safe to use without confirming the product is not recalled.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0327-2023 (February 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0327-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.