Clear Eyes Recalled 39,060 Bottles of Maximum Itchy Eye Relief for a “Lack of Assurance of Sterility.” One Lot, One Expiration Date, a Refund at the Register — and, as of Today, No Lawsuit. What the Class II Label Actually Means, and Why Eye Drops Are the One Product Where That Phrase Gets a Second Look.

Check the box and the bottle for the lot number. Other Clear Eyes products, and other lots of Maximum Itchy Eye Relief, are not part of this recall. The active ingredients on the label are glycerin, naphazoline hydrochloride and zinc sulfate — an over-the-counter decongestant-astringent drop sold for allergy itch.

FDA sorts recalls into three classes by the harm a product could do. Under 21 C.F.R. § 7.3(m), Class II is “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” Class I is reserved for a reasonable probability of serious harm or death; Class III is for products unlikely to cause any. Class II is the middle and the most common.

“Lack of assurance of sterility” is a manufacturing finding, not a laboratory one. It means the company could not demonstrate that the lot was sterile — a failed or missing control, a process deviation — not that bacteria or fungi were found in bottles. NBC and CBS, reporting on the FDA listing, described it the same way: the product is not known to be contaminated, but the manufacturer cannot say it is not. Prestige Consumer Healthcare did not respond to CBS News’s request for comment, and no adverse events had been reported as of those reports.

The phrase is not new to this brand. FDA’s enforcement database holds 19 Clear Eyes entries. In July 2019, Altaire Pharmaceuticals of Aquebogue, New York recalled Clear Eyes Redness Relief lots for the identical reason, “Lack of Assurance of Sterility,” and Medtech Products recalled more than a dozen Clear Eyes displays and lots — more than two million bottles across the entries — for “CGMP Deviations” at a manufacturing facility. Those recalls were completed years ago and are unrelated to lot 2552A, but they explain why regulators treat sterility paperwork on eye drops as seriously as a positive culture.

Eye drops go onto the one surface where a contaminant does not need to survive the stomach. The reference case is the 2023 outbreak tied to EzriCare and Delsam Pharma artificial tears, made by an Indian manufacturer, Global Pharma Healthcare, and contaminated with an extensively drug-resistant strain of Pseudomonas aeruginosa. By the CDC’s May 2023 update, that outbreak had reached 81 patients in 18 states, with four deaths, 14 people with vision loss and four surgical removals of an eye. That is what a contaminated eye drop can do, and it is why an agency listing that says only “potential contamination” still gets covered nationally. It is also the difference between that case and this one: there, a pathogen was found and matched to patients; here, nothing has been found and no one has reported being hurt.

There is no settlement, no claim form and no fund. The remedy, as reported by the outlets that covered the FDA listing, is to stop using the product and return it to the store for a refund; keep the box or a photo of the lot number. We searched the CourtListener RECAP archive for cases naming Clear Eyes, Prestige or Medtech and found nothing filed in 2026 — a finding limited by RECAP’s coverage, which is thin for state courts — and no news report of a class action as of September 3, 2026.

Recalls sometimes turn into lawsuits, and it is worth being precise about when. A consumer class action over a recalled over-the-counter product usually alleges economic loss — you paid for a sterile product and got one that could not be shown to be sterile — and such cases tend to settle for refund-sized amounts, if they survive at all when a refund is already on offer. A personal-injury claim is different in kind: it needs an injury (an infection diagnosed by a doctor), a causal link (a culture matching an organism in the product, or at minimum documented use of the recalled lot before onset), and the bottle or its lot number. If you used lot 2552A and then developed an eye infection, see an eye doctor first, keep the bottle, and ask the clinic to culture it. Without that chain there is no case; with it, there may be.