Nearly 40,000 bottles of over-the-counter eye drops have been removed from U.S. shelves after federal regulators identified sterility concerns. The recall targets Clear Eyes Maximum Itchy Eye Relief, according to an enforcement report from the Food and Drug Administration.
The FDA labeled the recall as Class II, indicating the product might cause temporary health issues but is unlikely to result in serious harm. The agency did not detail the contamination risk, describing it only as a “lack of assurance of sterility.”
Identifying the affected bottles
The recalled eye drops were sold in 15-milliliter bottles with an expiration date of September 30, 2027. The specific lot code is 2552A, and the product includes these identifiers:
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- National Drug Code (NDC): 67172-999-01
- Universal Product Code (UPC): 678112659203
- Distributed by: Medtech Products Inc.
The bottles were distributed nationwide, though the FDA did not specify which retailers or pharmacies received them. Prestige Brand Holdings, the company managing the recall, markets other over-the-counter products like Dramamine and Breathe Right nasal strips. It has not commented on the situation.
Consumer guidance
The FDA urges anyone who bought the recalled eye drops to stop using them immediately. Contaminated drops could cause eye infections. Customers should check their bottles for the listed lot code and expiration date.
While the agency did not provide return instructions, recalled products usually qualify for refunds or exchanges at the point of purchase. Buyers should contact the store where they purchased the drops to verify their options. The FDA has not indicated whether it will release further updates.
Industry-wide safety focus
The recall occurs as regulators intensify scrutiny of eye drop safety. Sun Pharma, one of India’s largest drug manufacturers, withdrew 10 brands of eye drops from the market due to similar contamination risks. The affected products, including Brinolar and Lotepred, were distributed across India, according to an internal company memo dated July 17.
The memo directed distributors to stop sales and return existing stock. A Sun Pharma representative stated the move was precautionary and that the company was working to restore supply.
Prestige Brand Holdings has not explained the cause of the sterility issue. The FDA’s report remains the main source of information, and the agency has not announced plans for a public briefing.
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