Class II · Moderate risk
Febuxostat Tablets 80mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Is Febuxostat recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Febuxostat (6 total). Check the affected lots below.
Most common reason: Microbial contamination (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Febuxostat. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Febuxostat recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets
CGMP Deviations
Class II · Moderate risk
Febuxostat Tablets 80 mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
FEBUXOSTAT Tablet
Labeling: Label Mixup; FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 59746000103, Pedigree: AD21811_17, EXP: 5/1/2014; tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: W002663, EXP: 6/5/2014; SODIUM CHLORIDE, Tablet, 1000 mg, NDC 00527111610, Pedigree: W003926, EXP: 7/1/2014.
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