Some recent news has put a spotlight on perils associated with pharmaceutical aseptic processing quality. Last week, FDA made public that K.C. Pharmaceuticals of California initiated a voluntary recall on March 3, 2026, covering more than 3.1 million bottles of over-the-counter (OTC) lubricating eye drops. The drops were sold under store brands at several major retail outlets. FDA classified the action as a Class II recall on March 31, and the enforcement report became public at that point.

The stated reason was a “lack of assurance of sterility,” meaning the company could not demonstrate its manufacturing process reliably excluded infection-causing microbes. There was no confirmed contamination and no reported injuries, but with aseptic manufacturing, realized user harm means that a vast number of things have gone wrong.

Eye drops, including those sold OTC, are regulated as sterile drug products. The surface of the eye has limited immune defenses, so drops made outside of current Good Manufacturing Practices (cGMP) pose a heightened risk of harm. Any drug used in the eyes must be sterile to reduce the risk of infection, but terminal sterilization at the end of the manufacturing process is often harsh and might affect the finished drug product. Makers of eye drops must therefore engage in aseptic processing, making and keeping the drops sterile but without the backstop of say, an autoclave, dry heat oven, or gamma radiation used at the end of the manufacturing process.

Achieving and maintaining that sterility across a commercial manufacturing operation is technically demanding. It presents a higher risk of microbial contamination than on that relies on terminal sterilization, as it involves more variables and any manual or mechanical manipulation of the sterilized drug, containers, or closures before or during filling poses contamination risk. Detritus from personnel—i.e., the dead skin and other microscopic refuse that falls off us all the time—are the single biggest contamination threat. Clean rooms must additionally maintain precise air pressure differentials, environmental monitoring, and batch testing. As the kids these days might say: aseptic processing hits different.

These concerns aren’t limited to eye drops. If you feel like you’re hearing a lot about peptides these days, you’re not imagining things. Like sterile eye drops, peptides are also made using aseptic practices because they are complex molecules that are heat sensitive. The drug substance is sterilized by filtration and then filled into vials or syringes in a clean room. Multiple contamination risks in the process pose danger. And as with eye drops, there is no kill step at the end.

FDA first flagged K.C. Pharmaceuticals in an August 2023 warning letter, citing failure to establish written procedures to prevent microbiological contamination, including validation of aseptic and sterilization processes, and finding that the aseptic processing operation was inadequately designed to prevent contamination of ophthalmic drug products. Prior to that letter, FDA had inspected the facility eight times over 13 years, with six of those inspections resulting in classifications of voluntary action indicated (VAI).

But as K.C. Pharmaceuticals shows us, the slope from a VAI classification to a warning letter and then national recall is a steep one in the world of aseptic processing. This seems especially true in the manufacture of eye drops. In 2023, 81 people in 18 states developed severe eye infections traced to contaminated eye drops. Fourteen lost their vision, four had their eyeballs surgically removed, and four tragically died. In response, FDA issued a revised draft guidance in December 2023 specifically to add microbiological considerations for ophthalmic drug sterility and contamination prevention for multidose containers. That revised draft guidance has not yet been finalized, and FDA’s own FY2024 pharmaceutical quality report noted that ophthalmic products topped the agency’s recall list. The failures share a common thread: aseptic process validation gaps, inadequate environmental monitoring, and quality units lacking authority.

The U.S. eye drops market was valued at $5.12 billion in 2024 and is projected to reach nearly $10 billion by 2034. That growth makes aseptic quality discipline both a regulatory obligation as well as a business necessity. The K.C. recall is a timely case study in what deferred enforcement and immature quality systems in rapidly expanding markets actually cost.

John Claud’s FDA Regulatory practice spans across all of FDA’s regulated industries, including helping manufacturers manage aseptic processing and responding to FDA inspections. He can be reached at john.claud@nelsonmullins.com or 202-689-2977.