K.C. Pharmaceuticals, Inc. has voluntarily recalled more than 3 million over‑the‑counter eye drop products distributed nationwide due to a lack of assurance of sterility, according to the U.S. Food and Drug Administration. The recall was initiated on March 3, 2026, and classified by the FDA as a Class II recall on March 31.
Clinical Considerations
- The FDA defines a Class II recall as one in which exposure may cause temporary or medically reversible adverse effects, with a low probability of serious harm.
- Recalled products include artificial tears, redness relievers, dry eye drops, and lubricating eye drops sold under multiple private‑label brands.
- Products were distributed through major retailers including CVS, Walgreens, and Kroger.
- The recall applies to over‑the‑counter products only; prescription ophthalmic medications are not affected.
Practice Applications
- For optometrists: Proactively ask patients about OTC eye drop use, especially those presenting with irritation, redness, or unexplained symptoms.
- For ophthalmologists: Reinforce that prescription therapies should be continued unless otherwise directed, as the recall does not apply to physician‑prescribed drops.
- For opticians and clinic staff: Be prepared to help patients identify recalled products and direct them to discard affected bottles.
- Across practices: Encourage patients to seek evaluation promptly if they experience pain, discharge, or vision changes after using recalled products.
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