K.C. Pharmaceuticals has recalled more than 3 million over-the-counter eye drop bottles due to a lack of assurance of sterility.
The Class II recall, initiated March 3, includes eight brands manufactured by K.C. and distributed nationwide under store-brand labels such as CVS Health, Walgreens, Kroger and Cardinal Health, according to a March 31 FDA enforcement report.
The affected products include dry eye relief, artificial tears, redness relief and lubricant eye drops across multiple lot numbers with expiration dates through October 2026. The largest segment — dry eye relief drops — includes 1,023,096 bottles, followed by 589,848 bottles and 378,144 bottles across other product lines.
The FDA said the recalled products may pose a contamination risk, which can lead to eye infections or more serious complications.
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