DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has initiated a nationwide recall of nearly 748,000 eye-care products due to concerns regarding sterility assurance. This action specifically affects more than 500,000 packages of Walgreens-branded lubricant eye drops. The recall was launched on Aug. 20 after issues emerged during a federal inspection. Subsequently, the U.S. Food and Drug Administration classified the recall as a Class II event. This classification indicates that the products could potentially cause temporary or medically reversible health effects, while the likelihood of serious consequences remains low.
Walgreens items constitute the largest portion of the recall, with federal records listing 500,714 packages. The total includes 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. Distribution of the affected products across the United States was carried out by Walgreen Co. Records show several affected lots with expiration dates extending into 2027.
In addition to Walgreens-branded items, the recall extends to products sold under various other brands and distributors. AvKare accounts for 120,241 twin packs of lubricant eye drops, while Reliable-1 Laboratories includes 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Several other products from Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals are also involved. Federal records indicate a total of 747,844 affected units across nine product listings associated with Sterling Pharmaceutical Services.
Federal inspection highlights sterility issues
AvKare stated that Sterling initiated the recall following a FDA’s request, which was based on observations made during a recent inspection. These findings involved manufacturing controls and aseptic processing, essential procedures used to prevent contamination in sterile drug products. AvKare clarified that Sterling had not identified confirmed sterility failures or evidence of contamination. The recall is considered precautionary because the inspection findings impacted sterility assurance. Customers were advised by AvKare to cease using the affected products.
Ensuring sterility is particularly critical for ophthalmic medications since they are applied directly to the eyes. The FDA attributes the current recall to a lack of sterility assurance. Federal records specify individual lot numbers and expiration dates for each impacted product. The scope of the recall encompasses Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals products, all traceable to Sterling’s manufacturing facility in Dupo, Illinois.
Majority of packages recalled are Walgreens products
Approximately two-thirds of the packages included in the recall are Walgreens lubricant eye drops. Affected lots of single bottles have expiration dates spanning from September 2026 to June 2027, while twin-pack lots are dated from September 2026 to July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the firm responsible for the recall, with distribution across the country documented. The FDA assigned the event number 99712 to this recall as part of its formal enforcement record.
This 2026 recall follows prior federal scrutiny of Sterling’s Illinois facility, though it remains a separate regulatory matter. In September 2022, the FDA issued Sterling a warning letter after inspecting the plant earlier that year. The letter cited deficiencies in manufacturing practices involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall specifically addresses sterility assurance issues following a more recent inspection. Sterling’s recall information, relayed by AvKare, confirms that no verified contamination or sterility failures have been identified thus far.