DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has pulled back nearly 748,000 eye-care items across the country amid sterility concerns. The recall includes over 500,000 Walgreens-branded lubricant eye-drop packages. The company announced the recall on Aug. 20, according to federal records. The U.S. Food and Drug Administration designated it as a Class II recall on Sept. 21, indicating that the affected products might cause temporary or reversible health issues, with serious harm considered unlikely.
Walgreens products make up 500,714 packages in the recall, including 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These items contain carboxymethylcellulose sodium 0.5% and are used to relieve dry-eye symptoms such as burning, irritation, and discomfort temporarily. The affected products were distributed nationwide by Walgreen Co. Federal records specify NDC 0363-8833-15 and list multiple lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall involves nine product lines across several brands. AvKare’s lubricant eye drops account for 120,241 twin packs across two listings. Reliable-1 Laboratories’ affected items include 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5%. The recall also covers Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. All together, these products sum to 747,844 units.
Recall prompted by FDA inspection results
AvKare stated Sterling initiated the recall at the FDA’s request following observations during a recent federal inspection. The issues involved manufacturing practices and aseptic processing controls, according to an Aug. 25 customer recall notice. AvKare emphasized that Sterling had not identified confirmed sterility failures or evidence of contamination. The notice described the action as precautionary, given that the inspection findings could impact sterility assurance. Customers were advised to cease using affected products immediately.
FDA regulations regard sterility as essential for medicines applied directly to the eyes. Because ophthalmic products can bypass some of the body’s natural defenses, sterile manufacturing and handling are crucial. The agency’s enforcement data point to lack of sterility assurance as the reason for the Sterling recall. Federal records specify lot numbers and expiration dates for each affected item. The recall includes products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens products comprise the majority of recalled units
Approximately two-thirds of the total 747,844 packages recalled are Walgreens lubricant eye drops. The impacted single bottles include lots with expiration dates from September 2026 through June 2027, while twin packs are set to expire from September 2026 through July 2027. The FDA enforcement record names Sterling Pharmaceutical Services of Dupo, Illinois, as the manufacturer conducting the recall, listing the products’ distribution nationwide and assigning event number 99712.
This 2026 recall follows previous FDA reviews of Sterling’s Dupo operations, though it is a separate regulatory matter. In September 2022, the FDA issued Sterling a warning letter after an inspection earlier that year, citing deficiencies in manufacturing practices related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current Walgreens eye drops recall concerns sterility assurance following a more recent FDA inspection. AvKare’s 2026 notice confirms Sterling found no confirmed sterility failure or contamination in the affected products.