The US Food and Drug Administration (FDA) has issued a warning regarding the sterility of certain eye ointments available at CVS and Walmart, potentially posing a risk of eye infections. The recall, initiated by Brassica Pharma, was posted by the FDA on February 26, encompassing several eye ointments with expiration dates spanning from February 2024 to September 2025.
According to the recall notice, an FDA inspection conducted at a Brassica facility uncovered a “lack of sterility assurance,” raising concerns about the possibility of eye infections resulting from product use.
Recall Details and Health Risks: FDA’s Concerns Over Contaminated Eye Products
This recall marks the latest in a series of FDA actions targeting eye products. In October of the previous year, the FDA cautioned consumers about 26 eye drop products linked to a serious eye infection, which could potentially lead to vision loss or blindness. The agency identified “unsanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility” as the underlying issues. Earlier in 2023, the FDA also issued warnings against the use of certain eye drop products due to microbial contamination.
The FDA emphasized the serious health risk posed by potential contamination, particularly when medications are applied directly to the eye, circumventing some of the body’s natural defense mechanisms.
FDA Announces Eye Ointments Recall
Retailers’ Response and Consumer Guidance: Steps Taken by CVS and Walmart
The recall by Brassica Pharma affects various brands of eye ointments available at popular retailers, including Equate Lubricant Eye Ointment (Walmart’s private label), Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, and Lubricant PM Ointment distributed by AACE Pharmaceuticals. Affected expiration dates have been listed by the FDA online.
In response to the recall, distributors such as Walmart, CVS, and AACE Pharmaceuticals are facilitating the return of all affected products. Customers are advised to discontinue the use of the recalled eye ointments and are encouraged to return them to the respective retailers.
CVS has confirmed the cessation of sales of the product, both in-store and online, since October 2023, with a full refund offered for returned items. Similarly, Walmart has taken measures to remove the product from its shelves in response to the recall.
The FDA’s prompt action underscores the importance of ensuring the safety and efficacy of healthcare products, particularly those directly impacting sensitive areas such as the eyes. Consumers are urged to remain vigilant and heed recall notices issued by regulatory authorities to safeguard their health and well-being.
