DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has begun a nationwide recall of nearly 748,000 eye-care products due to sterility assurance concerns. The recall includes over 500,000 packages of Walgreens-branded lubricant eye drops. The company announced the recall on Aug. 20 following issues identified during a federal inspection. The U.S. Food and Drug Administration classified this as a Class II recall, which involves products that might cause temporary or reversible health effects, with serious health consequences being unlikely.
Walgreens products constitute the majority of the recall, with 500,714 packages documented in federal records. This total comprises 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5%, which alleviates burning and irritation associated with dry eyes. Walgreen Co. distributed these affected items across the United States. Records reveal several impacted lots with expiration dates extending into 2027.
The recall also extends to products marketed under various other brands and distributors. AvKare reports 120,241 twin packs of lubricant eye drops affected by the recall. Reliable-1 Laboratories’ products include 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Additional affected products are linked to Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records indicate a total of 747,844 impacted units across nine product listings associated with Sterling Pharmaceutical Services.
Federal inspection prompts sterility concerns
AvKare explained that Sterling initiated the recall following the FDA’s request after findings from a recent inspection. These findings involved manufacturing controls and aseptic processing—techniques used to safeguard sterile drug products from contamination. AvKare noted that Sterling had not identified confirmed sterility failures or contamination of the products. The recall was described as a precautionary measure, given that the inspection results compromised sterility assurance. Customers were advised by AvKare to cease using the affected products.
Sterility safeguards are particularly crucial for ophthalmic medicines since they are directly applied to the eyes. The FDA emphasizes the lack of sterility assurance as the reason for this recall. Federal records specify individual lot numbers and expiration dates for each affected item. The recall involves Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals products, all linked to Sterling’s manufacturing facility in Dupo, Illinois.
Most of the recalled packages belong to Walgreens
Approximately two-thirds of all packages affected by the recall are Walgreens lubricant eye drops. The impacted single-bottle lots have expiration dates from September 2026 through June 2027, while twin-pack lots feature expiration dates from September 2026 through July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the responsible company for the recall, confirming distribution across the country. The FDA recorded the event under the recall event number 99712 as part of its official enforcement documentation.
This 2026 recall follows prior federal scrutiny of Sterling’s Illinois plant, though it remains a separate regulatory matter. In September 2022, the FDA issued Sterling a warning letter after inspecting the facility earlier that year. The letter pointed out deficiencies in manufacturing practices concerning sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall relates to sterility assurance concerns identified during a more recent inspection. According to AvKare’s communication, Sterling’s recall notice states that no confirmed contamination or sterility failure has been detected.