FDA Recalls Over 3 Million Bottles of Eye Drops

Scope of the recall

The Food and Drug Administration announced a voluntary Class II recall of more than 3 million over‑the‑counter eye‑drop bottles distributed nationwide. The recall involves eight batches sold under multiple brand names, including generic “Dry Eye Relief” and “Artificial Tears” formulations.

Who is involved

K.C. Pharmaceuticals, Inc., a Pomona, California distributor, issued the recall on March 3. Products reached major retailers such as Walgreens, CVS, Kroger, H‑E‑B, and military exchanges.

Reason for action

The FDA cited a “lack of assurance of sterility” after inspections revealed unsanitary conditions and positive bacterial cultures in the manufacturing environment. No injuries have been reported, but the agency warned that compromised sterility could cause temporary or reversible eye irritation.

What consumers should do

Consumers are advised to stop using the affected products immediately and return them to the point of purchase for a refund. The recall does not affect prescription eye medications.

Next steps

K.C. Pharmaceuticals is cooperating with the FDA to address the manufacturing deficiencies. The agency will monitor compliance and may issue further guidance if additional safety concerns arise.