More than 39,000 bottles of Clear Eyes Maximum Itchy Eye Relief are being recalled nationwide because of concerns that the product may not be sterile.
The recall covers 0.5-fluid-ounce bottles from lot 2552A with an expiration date of Sept. 30, 2027.
The FDA has classified the recall as Class II, a designation used when exposure could cause temporary or medically reversible health problems, though the likelihood of serious consequences is considered remote.
Consumers are being warned to check their medicine cabinets after nearly 40,000 bottles of Clear Eyes eye drops were recalled nationwide because of potential contamination concerns.
Prestige Brands Holdings voluntarily recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief after a manufacturing issue led to a lack of assurance that the product is sterile, according to the U.S. Food and Drug Administration's (FDA's) enforcement information. The recall was initiated July 29 and classified by the FDA on Aug. 14. Recent reports have also detailed the nationwide recall.
The recall applies specifically to Clear Eyes Maximum Itchy Eye Relief sold in 0.5-fluid-ounce, or 15-milliliter, dropper bottles. The affected bottles are from lot 2552A and have an expiration date of Sept. 30, 2027. About 39,060 bottles are included in the recall.
The products were distributed nationwide.
Why were the Clear Eyes drops recalled? The issue involves a "lack of assurance of sterility," according to reports citing the FDA enforcement record. That means the sterility of the affected eye drops cannot be assured; it does not necessarily mean that every recalled bottle is contaminated.
Sterility is particularly important for products applied directly to the eyes because contaminated ophthalmic products can potentially cause infections.
The FDA designated the action a Class II recall. The agency uses recall classifications to indicate the relative health hazard posed by a recalled product. FDA guidance says recalls may initially be announced by companies before the agency completes its hazard assessment and assigns a classification.
A Class II recall generally means use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
How to identify the recalled Clear Eyes drops
Consumers who have Clear Eyes products at home should check the bottle and packaging carefully. The recall does not cover all Clear Eyes eye drops.
The affected product is:
Product: Clear Eyes Maximum Itchy Eye Relief
Size: 0.5 fl. oz. (15 mL)
Lot: 2552A
Expiration date: Sept. 30, 2027
Quantity recalled: 39,060 bottles
Distribution: Nationwide
Consumers with an affected bottle should follow the recall instructions associated with the product and avoid assuming other Clear Eyes products are included simply because they carry the same brand name.
Anyone who experiences eye pain, unusual redness, discharge, changes in vision, or other concerning symptoms after using eye drops should seek advice from a healthcare professional.