DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall for nearly 748,000 eye-care products nationwide due to concerns regarding sterility assurance. Among the affected items are over 500,000 packages of Walgreens-branded lubricant eye drops. The recall process started on Aug. 20, following issues identified during a federal inspection. The U.S. Food and Drug Administration subsequently classified this as a Class II recall, indicating products that could cause temporary or reversible health effects, with serious consequences being unlikely.
Walgreens products constitute the largest portion of the recall, 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., with several lots identified as having expiration dates extending into 2027.
The recall extends beyond Walgreens to include items sold under various other brands and distributors. AvKare reports account for 120,241 twin packs of lubricant eye drops. Reliable-1 Laboratories’ products include 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Additionally, products from Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals are involved. Federal records show a total of 747,844 affected units across nine product listings associated with Sterling Pharmaceutical Services.
Federal inspection raised sterility concerns
AvKare stated that Sterling commenced the recall following a request from the FDA after findings from a recent inspection. These findings concerned manufacturing controls and aseptic processing, which are vital to prevent contamination of sterile drug products. AvKare clarified that Sterling had not discovered confirmed sterility failures or evidence of contamination. The company described the recall as a precautionary measure since the inspection results impacted sterility assurance. Customers were also advised to cease using the affected products.
Sterility controls are particularly critical for ophthalmic medications because they are applied directly to the eyes. The FDA cites lack of sterility assurance as the primary reason for this recall. Federal records specify lot numbers and expiration dates for each affected product. The scope includes Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals items. Each is linked to Sterling’s manufacturing facility located in Dupo, Illinois.
Most recalled packages are from Walgreens
Approximately two-thirds of all packages subject to the recall are Walgreens lubricant eye drops. The affected lots of single bottles have expiration dates spanning from September 2026 through June 2027, while twin-pack lots are dated from September 2026 to July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the entity responsible for the recall, with distribution across the country. The FDA assigned the event number 99712 to this recall as part of its official enforcement documentation.
This 2026 recall follows earlier federal scrutiny of Sterling’s Illinois facility, though it remains a separate regulatory action. 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, prompted by more recent inspections, concerns sterility assurance. According to Sterling’s recall information relayed by AvKare, no confirmed contamination or sterility failure has been identified to date.