Yes — there is an active recall. 1 ongoing FDA recall mention Ketotifen (4 total). Check the affected lots below.
Most common reason: cGMP deviation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ketotifen. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
CGMP Deviations: products were stored outside the drug label specifications.
CGMP Deviations
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.
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