DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has initiated a nationwide recall of nearly 748,000 eye-care products amid concerns regarding sterility assurance. This recall includes more than 500,000 packages of Walgreens-branded lubricant eye drops. The company began the process on Aug. 20 following issues identified during a federal inspection. The U.S. Food and Drug Administration subsequently classified the recall as a Class II action. Such classifications typically involve products that might cause temporary or medically reversible health effects, with serious health outcomes being unlikely.
The majority of the affected units are Walgreens products, with federal records listing 500,714 packages. This 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. The affected items were distributed across the United States by Walgreen Co. and include lots with expiration dates extending into 2027, according to official records.
The recall also impacts products sold under various other brand names and distribution channels. Listings from AvKare account for 120,241 twin packs of lubricant eye drops. Additionally, Reliable-1 Laboratories supplies include 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Other affected products carry the names of Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records indicate a total of 747,844 affected units across nine product listings linked to Sterling Pharmaceutical Services.
Federal inspection raised concerns over sterility
Following an inspection, AvKare stated that Sterling initiated the recall at the FDA’s request after finding issues related to manufacturing controls and aseptic processing. These procedures are essential in safeguarding sterile drug products from contamination. AvKare noted that Sterling had not confirmed sterility failures or found evidence of contamination. The recall was deemed precautionary because the inspection results affected the company’s sterility assurance. Customers were advised by AvKare to cease using the affected products.
Sterility controls are particularly critical for ophthalmic medications because they are applied directly to the eyes. The FDA explains that the main reason for the recall is the 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 items, all originating from Sterling’s manufacturing facility in Dupo, Illinois.
Walgreens products constitute the majority of recalled packages
Nearly two-thirds of all packages recalled are Walgreens lubricant eye drops. Lots affected with single bottles have expiration dates from September 2026 through June 2027, while twin-pack lots have dates from September 2026 to July 2027. The Federal enforcement records identify Sterling Pharmaceutical Services as the recalling entity and confirm the products’ distribution across the country. The FDA designated the recall event number 99712 as part of its official enforcement documentation.
This 2026 recall follows earlier federal investigations into Sterling’s Illinois facility, although 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 concerns sterility assurance issues following a more recent inspection. According to AvKare, Sterling’s recall information indicates that no confirmed contamination or sterility failures had been identified at that time.