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Sterling Pharmaceutical Services has recalled nearly 750,000 eye-care products, including over 500,000 Walgreens-branded units, due to a lack of assurance of sterility.
Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, has initiated a voluntary recall of nearly 750,000 eye-care products due to sterility concerns. The recall, which began on Aug. 20, affects products sold under several brand names, including Walgreens, AvKare, and Reliable-1 Laboratories.
The U.S. Food and Drug Administration (FDA) classified the recall as Class II on Sept. 21. According to the FDA, this designation means that "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."
The company cited a "lack of assurance of sterility" as the reason for the recall. The FDA notes that ophthalmic products pose a heightened risk because drugs applied to the eyes bypass some of the body's natural defenses, requiring them to be sterile to reduce infection risks.
The recall covers nine specific products totaling 747,844 units. Walgreens-branded products account for the majority of the recall, with more than 500,000 units affected. The specific quantities and brands are as follows:
Federal health officials expanded the recall on Sept. 29 by adding additional lots for several brands. Lot numbers and expiration dates vary by brand and package size.
The FDA advises customers who believe they have any of the recalled products to immediately stop using them and to speak with their doctors. As of the reporting date, no injuries or other health concerns have been reported from the use of the eye drops.
A representative for Walgreens did not immediately respond to requests for comment. Sterling Pharmaceutical Services has not issued a news release regarding the recall, having notified consignees by letter instead.
This recall highlights the critical importance of sterility in ophthalmic products, which are administered directly to a sensitive area of the body. While the FDA classifies this as a Class II recall—indicating a remote probability of serious harm—the sheer volume of affected units, particularly the popular Walgreens brand, underscores the widespread nature of the distribution and the need for consumers to check their home medical supplies against the specific lot numbers provided by the FDA.
Sources
This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.
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