KC Pharmaceuticals recalled 3M+ eye-drop bottles for Pseudomonas contamination — the same plant had an FDA sterility warning in 2023

KC Pharmaceuticals' Eye Drop Plant Failed FDA Sterility Standards in 2023. They Kept Shipping.

In April 2026, KC Pharmaceuticals recalled more than 3 million bottles of eye drops sold nationwide at CVS, Walgreens, and Kroger after Pseudomonas aeruginosa contamination was confirmed. It was the company's second sterility failure at the same manufacturing facility in three years.

The 2023 Warning Letter

The FDA issued a warning letter to KC Pharmaceuticals in 2023 following an inspection that identified sterility assurance failures at the facility. Warning letters are the agency's formal mechanism for putting manufacturers on notice that their processes do not meet Current Good Manufacturing Practice (CGMP) standards. KC Pharmaceuticals did not shut down production. It continued manufacturing and distributing sterile ophthalmic products from the same plant.

The Second Failure

Pseudomonas aeruginosa is an opportunistic bacterium that can cause serious eye infections including bacterial keratitis, which can progress to corneal perforation and permanent vision loss. The organism is particularly dangerous in immunocompromised patients. Finding it in a sterile eye-drop product is not a minor deviation. It is a complete manufacturing failure.

The Pattern

Two sterility failures at the same plant. Continued distribution to three of the largest pharmacy chains in the United States between failures. The FDA warning letter did not stop production. Only a contamination event that reached consumers triggered a recall. The question for regulators is why the 2023 warning letter was not enforced with a mandatory shutdown.