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

5 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2014 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class III · Low risk

Eye Drops Advanced Relief

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Terminated cGMP deviation K C Pharmaceuticals Inc D-0323-2015
Class III · Low risk

Eye Drops Industrial Strength

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Terminated cGMP deviation K C Pharmaceuticals Inc D-0322-2015
Class III · Low risk

Eye Drops A.C.

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Terminated cGMP deviation K C Pharmaceuticals Inc D-0321-2015
Class III · Low risk

Eye Drops (Tetrahydrozoline HCl 0.05%)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Terminated cGMP deviation K C Pharmaceuticals Inc D-0320-2015
Class III · Low risk

Z-Cote Hp 1 Transparent Zinc Oxide

cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.

Terminated cGMP deviation Nanophase Technologies Corporation D-0238-2015

Recalls by year