Class II · Moderate risk
Amphotericin B Liposome for Injection
Out of specification for assay
Is Amphotericin B recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Amphotericin B (17 total). Check the affected lots below.
Most common reason: Labeling / mix-up (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amphotericin B. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Amphotericin B recalls on record
none so far in 2026; 17 on record, newest first
Class II · Moderate risk
Amphotericin B Liposome for Injection
Subpotent drug
Class II · Moderate risk
Abelcet (Amphotericin B Lipid Complex)
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
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.
Class II · Moderate risk
Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Liposomal Amphotericin B 130 mg in dextrose bags
Lack of sterility assurance.
Class II · Moderate risk
Amphotericin B active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Class II · Moderate risk
Amphotericin B Ophthalmic
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Tobramycin 1.4%
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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