DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall for nearly 748,000 eye-care products nationwide amid sterility concerns. This recall involves more than 500,000 packages of Walgreens-branded lubricant eye drops. The company began the voluntary recall on Aug. 20 following issues identified during a federal inspection. The U.S. Food and Drug Administration classified this action as a Class II recall, which involves products that might cause temporary or reversible health effects, with serious outcomes considered unlikely.
Walgreens products constitute the largest portion of the recall, with 500,714 packages recorded in federal documentation. This total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5%, a substance used to alleviate burning and irritation associated with dry eyes. Distributing the affected items across the U.S., Walgreen Co. has records indicating several impacted lots with expiration dates extending into 2027.
The scope of the recall also extends to products marketed under various other brands and distributors. AvKare’s listings include 120,241 twin packs of lubricant eye drops, while Reliable-1 Laboratories’ products encompass 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Additional affected items are associated with Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal recall records show a total of 747,844 units impacted across nine product listings linked to Sterling Pharmaceutical Services.
Federal inspection raised sterility concerns
According to AvKare, Sterling initiated the recall at the FDA’s request following observations made during a recent inspection. These findings involved manufacturing controls and aseptic processing, procedures essential to protecting sterile drug products from contamination. AvKare stated that Sterling had not discovered confirmed sterility failures or evidence of product contamination. The company described the recall as precautionary, noting that the inspection results cast doubt on sterility assurance. They also advised customers to cease using the affected products.
Sterility control measures are especially critical for ophthalmic medications because consumers apply them directly to their eyes. The FDA’s reason for the current recall is listed as a lack of assurance of sterility. Federal records specify individual lot numbers and expiration dates for each affected product. The recall encompasses products sold by Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. All these products originate from Sterling’s manufacturing facility in Dupo, Illinois.
Majority of recalled packages are Walgreens products
Approximately two-thirds of all packages subject to the recall are Walgreens lubricant eye drops. The affected single-bottle lots have expiration dates from September 2026 to June 2027, while the twin-pack lots span from September 2026 through July 2027. Federal enforcement records confirm Sterling Pharmaceutical Services as the recalling entity, with distribution across the nation. The FDA has assigned the recall event number 99712 as part of its official enforcement documentation.
This 2026 recall follows earlier federal scrutiny of Sterling’s Illinois plant, although it remains a separate regulatory process. In September 2022, the FDA issued Sterling a warning letter after inspecting the facility earlier that year. The letter cited deficiencies in manufacturing practices related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall pertains to sterility assurance issues identified during a more recent inspection. According to the recall details provided by AvKare, no confirmed contamination or sterility failures have been detected so far.