Prestige Brands Holdings, a Tarrytown, New York-based company, has voluntarily recalled 39,060 15 milliliter bottles of its Clear Eyes Maximum Itch Eye Relief drops. According to the FDA’s recall report, the product could contain harmful contaminants. The FDA lists the reason for the recall as “lack of assurance of sterility.”
The FDA first initiated the recall on July 29. On Aug. 14, the organization classified the recall as a Class II recall, meaning the “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.” The FDA says if you purchased a bottle of the recalled drops, stop using them immediately, throw them away, or return them to the place of purchase for a refund.
How to check if your eye drops are recalled
The report states that the affected product has a lot number of 2552A and an expiration date of Sept. 30, 2027. The eye drops were distributed nationwide. The FDA says if you purchased a bottle of the recalled drops, stop using them immediately, throw them away, or return them to the place of purchase for a refund.
The latest recall follows a number of major eye drop recalls recently, which have been made over similar concerns. In March, K.C. Pharmaceuticals recalled more than 3 million bottles of lubricating eye drops sold under different names over concerns they had not been properly tested for sterility.
Just months later, a voluntary recall of over 2.5 million bottles of prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, a prescription-based eye drop manufactured by Lupin Limited, was issued due to the possible “presence of a foreign substance.” The following month, around 12 million Rohto cooling eye drop products were also recalled over “lack of assurance of sterility.”
Why sterility matters
No injuries or issues have been publicly reported in regard to the latest recall, but according to a June 2026 notice from the FDA, the wave of recent recalls over sterility concerns prevents a number of possible medical issues. “There have been several recent safety recalls related to OTC eye drop products. These recalls resulted from various safety concerns, including reports of infections, partial loss of vision, and blindness. The recalls were due to product contamination risks,” the notice explains.
While the risk of serious issues is remote, in some cases, complications from eye drops have occurred. In October of 2023, the FDA told customers to stop purchasing 26 different kinds of over-the-counter eye drop products due to a risk of eye infection that could result in partial vision loss or even blindness.
The serious recall stemmed from a drug-resistant bacteria that ultimately led to 81 reported infections, four deaths, 14 people who experienced vision loss, and four who had to have their eyeballs surgically removed.
