DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has recalled nearly 748,000 eye-care products nationwide over concerns about sterility assurance. The action includes more than 500,000 Walgreens-branded lubricant eye-drop packages. Sterling began the recall on Aug. 20 after issues surfaced during a federal inspection. The U.S. Food and Drug Administration later classified the action as a Class II recall. That classification covers products that could cause temporary or medically reversible health effects, while serious consequences remain unlikely.
Walgreens products make up the largest share of the recall, with 500,714 packages listed in federal records. The total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. The products contain carboxymethylcellulose sodium 0.5%, which helps relieve burning and irritation linked to dry eyes. Walgreen Co. distributed the affected products across the United States. Records identify several affected lots with expiration dates that extend into 2027.
The recall also covers products sold under several other brands and distributors. AvKare 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 products carry the Cameron Pharmaceuticals, TRP and Major Pharmaceuticals names. Federal recall records show 747,844 affected units across nine product listings tied to Sterling Pharmaceutical Services.
Federal inspection raised sterility concerns
AvKare said Sterling started the recall at the FDA’s request after observations from a recent inspection. Those findings involved manufacturing controls and aseptic processing, which companies use to protect sterile drug products from contamination. AvKare said Sterling had not found confirmed sterility failures or evidence of product contamination. The company described the recall as precautionary because the inspection findings affected assurance of sterility. AvKare also told customers to stop using its affected product.
Sterility controls carry added importance for ophthalmic medicines because consumers apply them directly to the eyes. The FDA lists lack of assurance of sterility as the reason for the current recall. Federal records identify individual lot numbers and expiration dates for each affected product. The action covers Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP and Major Pharmaceuticals products. Each listing traces back to Sterling’s manufacturing operation in Dupo, Illinois.
Walgreens items represent most recalled packages
Walgreens lubricant eye drops account for roughly two-thirds of all packages included in the recall. Affected single-bottle lots have expiration dates ranging from September 2026 through June 2027. Twin-pack lots carry dates from September 2026 through July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the recalling firm and show nationwide distribution. The FDA assigned the recall event number 99712 as part of its formal enforcement record.
The 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 manufacturing practice deficiencies involving sterile ophthalmic products, contamination investigations and aseptic processing controls. The current recall concerns sterility assurance following a more recent inspection. Sterling’s recall information, as relayed by AvKare, states that no confirmed contamination or sterility failure had been identified.