Full Breakdown
Clear Eyes Maximum Itchy Eye Relief Recall Over Sterility Concerns
8/26/2026, 12:55:49 AM
Recall Overview
Prestige Brand Holdings, the owner of the Clear Eyes line, announced a voluntary recall of its Clear Eyes Maximum Itchy Eye Relief eye drops because the U.S. Food and Drug Administration (FDA) could not verify that the product is sterile. The recall began on July 29 and was reiterated by the FDA on August 14. It applies nationwide to 15-milliliter bottles sold at major retailers such as Walmart, Target, CVS, Kroger, Dollar General and Family Dollar.
Scope and Details
- Quantity: The FDA notice lists 39,060 bottles; other reports describe the recall as covering “nearly 40,000 bottles.”
- Lot code: Most sources identify lot code 2552A; one source cites 2252A, creating a discrepancy.
- Expiration: All affected bottles carry an expiration date of September 30, 2027.
- Recall class: The FDA classified the action as a Class II recall, meaning exposure to the product could cause temporary or medically reversible health effects, though the probability of serious harm is remote.
Official Agency and Company Response
The FDA’s classification emphasizes that the lack of sterility assurance poses a potential risk, but no confirmed contamination has been reported. Consumers are instructed to stop using the product and return it to the point of purchase for a full refund. The company’s customer-service line is 800-443-4908, and additional inquiries can be directed via the Clear Eyes website.
Conflicting Reports & Gaps
- Lot code variance: The majority of outlets cite lot 2552A, while one source lists lot 2252A. No clarification has been provided by the manufacturer or the FDA.
- Bottle count: Reported figures range from 39,060 to “nearly 40,000” bottles, indicating a lack of precise public disclosure of the total units affected.
Verbatim Quotes
- “Consumer safety is our No. 1 priority,” — Phil Terpolilli, a spokesperson for the company, in an email Sunday
Impact and Consumer Guidance
No injuries or illnesses have been reported in connection with the recalled eye drops. The recall underscores the FDA’s heightened scrutiny of sterile ophthalmic products, especially after 2023 recalls of two eye-drop brands linked to drug-resistant bacterial infections that resulted in multiple deaths. Consumers should discard any affected bottles, retain proof of purchase for refunds, and monitor the FDA’s website for updates on the recall status.
