Key Takeaway:
- The Clear Eyes eye drops recall involves 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops recalled nationwide over sterility concerns.
- The recall affects 15 mL bottles, lot 2552A, expiring Sept. 30, 2027.
- Consumers should stop using affected bottles and check with the retailer about return options.
Prestige Brand Holdings is recalling 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops nationwide because of concerns about sterility, the FDA said.
FDA Cites Sterility Concerns In Nationwide Recall
The voluntary Clear Eyes eye drops recall involves 15-milliliter bottles of Clear Eyes Maximum Itchy Eye Relief distributed across the United States. The FDA listed the recall in its enforcement report and classified it as a Class II recall.
The agency defines a Class II recall as one involving a product that could cause temporary or medically reversible health effects, or when the likelihood of serious harm is remote.
The FDA cited a “lack of assurance of sterility” as the reason for the recall. The agency did not state in the enforcement report that contamination had been confirmed in the recalled bottles.
The Clear Eyes eye drops recall affects eye drops that relieve itchy, dry, burning, and irritated eyes. The product contains glycerin, naphazoline hydrochloride, and zinc sulfate, according to the FDA-listed drug label.
Check The Bottle For These Recall Details
Consumers can identify the recalled product by checking the bottle and packaging for specific details related to the Clear Eyes eye drops recall.
The affected product is a 15-milliliter bottle with an expiration date of Sept. 30, 2027. The recalled lot carries the code 2552A.
The product’s National Drug Code is 67172-999-01, while its Universal Product Code is 6 78112 65920 3. The FDA recall number is D-0766-2026.
The FDA-listed product information identifies Prestige Brands Holdings Inc. as the labeler. DailyMed, which publishes FDA-linked drug labeling information, also identifies Prestige Brands Holdings as the manufacturer and lists the same 15-milliliter product and NDC.
The product’s labeling warns users to avoid contamination by not allowing the bottle tip to touch any surface. It also says users should stop using the drops and seek medical advice if they experience eye pain, vision changes, continued redness or irritation, or worsening symptoms.
Consumers Should Stop Using Affected Bottles
Consumers who have a bottle matching the recalled lot should not use it because of the sterility concern. The Clear Eyes eye drops recall does not currently include details from the FDA about confirmed infections or other specific injuries linked to the affected lot.
Prestige Brands Holdings, a consumer health care company, markets and distributes over-the-counter products including Dramamine, Breathe Right and Monistat.
The company did not immediately respond to a request for comment in the information provided for the recall report.
Consumers should check their bottles against the lot number, expiration date, and product codes before using them. They can also contact the retailer where they purchased the product to ask about return or replacement options.
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