Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Eye Drops & Ophthalmic Recalls

Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.

673 recalls in this category, newest first.

Class II · Moderate risk

Ketotifen Fumarate 0.025 %

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.

Ongoing cGMP deviation RemedyRepack Inc. NDC 70518-1142-00 D-0577-2023
Class II · Moderate risk

Ak-Poly-Bac

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Ongoing Stability / shelf life Akorn, Inc. D-0788-2023