FDA Class II Recall Covers 3.1 Million Bottles of Eye Drops Sold at Major U.S. Chains

The FDA has announced a Class II recall of more than 3.1 million bottles of over‑the‑counter eye drops manufactured by K.C. Pharmaceuticals and sold nationwide under at least eight brand names at Walgreens, CVS, Kroger, Rite Aid, Publix, H‑E‑B, Harris Teeter, Meijer, Dollar General, Circle K and other outlets. The March 3 recall, prompted by concerns about product sterility, covers lubricating drops, redness relievers and “advanced relief” formulas, including over 1 million bottles of Dry Eye Relief Eye Drops and hundreds of thousands of bottles of Artificial Tears Sterile Lubricant Eye Drops and various Walgreens‑branded sterile drops. The FDA classed the action as Class II, meaning any adverse health effects are expected to be temporary or medically reversible and the chance of serious harm is considered remote, distinguishing it from a separate 2023 eye‑drop recall tied to bacterial contamination. Consumers who purchased the listed products are advised to stop using them and check specific lot and brand information against the FDA notice or pharmacy guidance for next steps, a development that is already prompting questions online about over‑the‑counter drug manufacturing oversight and how to verify the safety of store‑brand eye care products.