DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has initiated a nationwide recall of nearly 748,000 eye-care items because of sterility assurance issues. This includes over 500,000 packages branded under Walgreens. The recall process started on Aug. 20, following findings during a federal inspection. The U.S. Food and Drug Administration subsequently categorized the recall as a Class II event. This classification indicates that the products could temporarily or reversibly impact health, with serious outcomes being unlikely.
Walgreens products constitute the largest portion of the recall, with federal records listing 500,714 packages. Among these are 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5%, a compound used to alleviate burning and irritation from dry eyes. The affected items were distributed nationwide by Walgreen Co., with records showing several lots with expiration dates extending into 2027.
The scope of the recall extends to products marketed under various other brands and distributors. For instance, AvKare listings include 120,241 twin packs of lubricant eye drops. Meanwhile, products from Reliable-1 Laboratories include 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. The recall also encompasses items from Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records indicate a total of 747,844 units affected across nine product listings linked to Sterling Pharmaceutical Services.
Federal Inspection Identifies Sterility Risks
Following recent inspections, AvKare announced that Sterling initiated the recall at the FDA’s request. The concerns stem from issues related to manufacturing controls and aseptic processing—methods employed to prevent contamination in sterile drug production. Although Sterling had not found confirmed sterility failures or contamination evidence, AvKare described the recall as a precaution, citing inspection findings that impacted sterility assurance. Customers were advised to discontinue use of affected products.
Sterility is especially critical for ophthalmic medicines because they are directly applied to the eyes. The FDA has cited the lack of sterility assurance as the primary reason for this recall. Federal records specify lot numbers and expiration dates for each affected item, which include products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. All of these are traced back to Sterling’s manufacturing facility in Dupo, Illinois.
Majority of Packages Recalled Are Walgreens Items
Nearly two-thirds of all packages affected by the recall are Walgreens lubricant eye drops. The lots with single bottles have expiration dates from September 2026 to June 2027, while twin-pack lots span from September 2026 through July 2027. Federal records identify Sterling Pharmaceutical Services as the entity responsible for the recall, with distribution across the country. The FDA assigned the official event number 99712 for this recall as part of its formal enforcement documentation.
This 2026 recall follows previous federal investigations into Sterling’s Illinois facility, although 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 highlighted deficiencies related to sterile ophthalmic manufacturing practices, contamination investigations, and aseptic processing controls. The current recall focuses on sterility assurance following a more recent inspection, with Sterling’s recall details, as communicated by AvKare, indicating that no confirmed contamination or sterility failure has been identified.