The Food and Drug Administration (FDA) has issued a Class II recall for nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops due to concerns about potential contamination. Prestige Brand Holdings, based in Tarrytown, New York, voluntarily initiated the recall because of a “lack of assurance of sterility,” according to an FDA enforcement report.
Key Takeaways
The FDA has issued a Class II recall for nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops due to sterility concerns. The recalled products were distributed nationwide and have an expiration date of September 30, 2027.
- Prestige Brand Holdings voluntarily recalled 39,060 bottles
- Recall classified as Class II by the FDA for moderate-risk situation
- Affected lot code is 2552A with expiration date of September 30, 2027
- Product sold at major retailers including Walmart and Target
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▼Source Claims Check
High ConsensusAll 3 publishers report consistent facts across 3 key claims.
| Claim | Status | Reason | |
|---|---|---|---|
| Recall Classification | Broad Agreement | Class II recall for moderate-risk situation | |
| Number Of Bottles Recalled | Broad Agreement | 39,060 bottles recalled | |
| Recall Reason | Broad Agreement | lack of assurance of sterility |
Recall Classification
Broad AgreementClass II recall for moderate-risk situation
Number Of Bottles Recalled
Broad Agreement39,060 bottles recalled
Recall Reason
Broad Agreementlack of assurance of sterility
This analysis is AI-generated and may not perfectly represent each source's reporting. Always read the original articles for full context.
The recall specifically covers 15ml bottles with lot code 2552A and an expiration date of September 30, 2027. The eye drops were distributed nationwide by Medtech Products Inc., a subsidiary of Prestige Consumer Healthcare, and sold at major retailers including Walmart, Target, Kroger, Giant Eagle, Meijer, Dollar General, and Family Dollar stores.
The FDA classified the action as a Class II recall, defined as a moderate-risk situation “in which 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.” Consumers are advised to stop using the recalled eye drops and return them for a refund. Anyone concerned about possible effects from the product is encouraged to contact a pharmacist or healthcare provider.
This recall comes amid ongoing concerns over the safety of eye drops in the US, following an incident in 2023 when EzriCare Artificial Tears were linked to an outbreak of Pseudomonas aeruginosa, a drug-resistant bacterial contamination. That outbreak resulted in one death and injuries to 68 other people.
How this summary was created
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