Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

398 recalls, newest first

Class II · Moderate risk

Sodium Chloride Ophthalmic Ointment USP

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Terminated Sterility / contamination Akorn, Inc. NDC 17478-622-35 D-1496-2022
Class II · Moderate risk

Lidocaine Hydrochloride Jelly USP

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Terminated Sterility / contamination Akorn, Inc. NDC 17478-711-31 D-1495-2022
Class II · Moderate risk

Difluprednate Ophthalmic Emulsion

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Terminated Sterility / contamination Cipla NDC 69097-341-35 D-1499-2022
Class II · Moderate risk

Difluprednate Ophthalmic Emulsion

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Terminated Sterility / contamination Cipla NDC 76282-708-50 D-1498-2022

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