Class II · Moderate risk
Fluconazole 200mg Ns 100ml
Lack of sterility assurance
Is Fluconazole recalled?
Not under an active recall.
Fluconazole was recalled 23 times in the past — all now closed. Most recent: Dec 27, 2022.
Most common reason: Sterility / contamination (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluconazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Fluconazole recalls on record
none so far in 2026; 23 on record, newest first
Class III · Low risk
Fluconazole Injection
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Class III · Low risk
Fluconazole Injection
Failed Stability Specifications: lot out of specification for elevated water vapor.
Class III · Low risk
Fluconazole Injection
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Class II · Moderate risk
Fluconazole Injection
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Class II · Moderate risk
Fluconazole USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
Fluconazole Injection
Superpotent
Class II · Moderate risk
Fluconazole Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk
Fluconazole Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Fluconazole Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class II · Moderate risk
All fluconazole Products
Lack of Processing Controls
Class II · Moderate risk
Fluconazole Injection
Cross contamination with other products: metronidazole
Class II · Moderate risk
FLUCONAZOLE IN NACL 400MG in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Class II · Moderate risk
Fluconazole active pharmaceutical ingredient packaged in varying…
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
GREENSTONE BRAND fluconazole for Oral Suspension
Defective Container: Tamper evident ring failures discovered on some bottles.
Class III · Low risk
Fluconazole Oral Suspension
Failed Stability Specifications: this product is below specification for preservative content.
Class II · Moderate risk
Flucon/Gent*
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
Fluconazole
Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014; FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014.
Class II · Moderate risk
Fluconazole
Labeling:Label Mixup; FLUCONAZOLE, Tablet, 100 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003086, EXP: 6/12/2014.
Class II · Moderate risk
Fluconazole
Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: W003065, EXP: 6/12/2014.
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