DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall of nearly 748,000 eye-care products across the country due to concerns related to sterility assurance. The recall includes more than 500,000 packages of Walgreens-branded lubricant eye drops. The company started the process on Aug. 20 following issues identified during a federal inspection. The U.S. Food and Drug Administration later classified this as a Class II recall, indicating the products could cause temporary or medically reversible health effects, although serious health consequences are unlikely.
Walgreens products constitute the largest portion of the recall, with 500,714 packages documented in federal records. This 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 items was carried out nationwide by Walgreen Co., and records show several lots with expiration dates extending into 2027.
The scope of the recall extends to products marketed under various other brands and distributors. AvKare’s listings 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. Additional affected items carry the names Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records detail a total of 747,844 affected units across nine product listings linked to Sterling Pharmaceutical Services.
Federal Inspection Uncovers Sterility Concerns
AvKare reported that Sterling initiated the recall at the FDA’s request following observations from a recent inspection. These findings involved manufacturing controls and aseptic processing, which are procedures used to prevent contamination of sterile drug products. AvKare emphasized that Sterling had not identified confirmed sterility failures or evidence of product contamination. The recall was deemed precautionary because the inspection findings impacted sterility assurance. AvKare also instructed customers to discontinue use of the affected products.
Since ophthalmic medicines are applied directly to the eyes, sterility controls are especially critical. The FDA states that the primary reason for the recall is the lack of assurance regarding sterility. Federal records specify individual lot numbers and expiration dates for each affected product. This recall impacts Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals items, all traced back to Sterling’s manufacturing plant in Dupo, Illinois.
Most Packages Recalled Are from Walgreens
Nearly two-thirds of the packages involved in the recall are Walgreens lubricant eye drops. Lots of affected single-bottle products have expiration dates from September 2026 through June 2027, while twin-pack lots have dates from September 2026 through July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the manufacturer responsible for the recall, which was distributed nationwide. The FDA assigned the event number 99712 as part of its official record of enforcement actions.
This 2026 recall follows earlier 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 pointed to manufacturing practice deficiencies related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall pertains to sterility assurance following a more recent inspection. According to AvKare, Sterling’s recall details indicate no confirmed contamination or sterility failures have been identified to date.