REGULATORY INTELLIGENCE·Recall
K.C. Pharmaceuticals Recalls 589,848 Artificial Tears Bottles Over Sterility Concerns, Impacting Major US Brands
K.C. Pharmaceuticals, Inc. has initiated a Class II recall for 589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops due to a critical "Lack of Assurance of Sterility." This nationwide U.S. recall, affecting multiple major brands including Leader and Good Sense, demands immediate action from procurement and supply chain leaders. Businesses must assess their exposure to K.C. Pharmaceuticals, Inc. and expedite qualification of alternative ophthalmic product manufacturers to mitigate supply disruption and patient safety risks.
90-Day Activity
K.C. Pharmaceuticals,ARTIFICIAL TEARS
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2026-04-08 Recall