DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has pulled back nearly 748,000 eye-care products across the country amid worries about sterility assurance. This recall includes over 500,000 packages of Walgreens-branded lubricant eye drops. The company announced the recall on Aug. 20, according to federal records. On Sept. 21, the U.S. Food and Drug Administration classified it as a Class II recall, which involves products that might cause temporary or medically reversible health effects, with serious harm considered unlikely.
Walgreens products make up 500,714 packages in this recall. This total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5% and are meant to provide temporary relief from dry-eye symptoms like burning, irritation, and discomfort. Distribution of the affected items was carried out nationwide by Walgreen Co. Federal records specify NDC 0363-8833-15 and list multiple affected lots with expiration dates stretching into 2027.
The broader Sterling Pharmaceutical Services recall encompasses nine product listings across various brands. AvKare lubricant eye drops account for 120,241 twin packs from two different listings. Reliable-1 Laboratories’ products 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. Altogether, these human eye-care products total 747,844 units.
Recall initiated following FDA inspection findings
AvKare stated that Sterling began the recall at the FDA’s request after observations made during a recent federal inspection. These involved manufacturing and aseptic processing controls, according to an Aug. 25 customer recall notice. AvKare clarified that Sterling had not identified confirmed sterility failures or signs of contamination in the products. The recall was described as precautionary, since the inspection findings could impact sterility assurance. Customers were instructed to cease using the affected products immediately.
The FDA considers sterility a crucial requirement for medicines applied directly to the eyes. Since ophthalmic products bypass some of the body’s natural defenses, maintaining sterile manufacturing and handling is essential. The agency’s enforcement data points to lack of sterility assurance as the reason behind the Sterling recall. Federal records specify lot numbers and expiration dates for each affected item. The recall covers products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens items constitute the majority of the recalled units
About 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. Twin-pack lots have expiration dates ranging from September 2026 to July 2027. The FDA enforcement record identifies Sterling Pharmaceutical Services of Dupo, Illinois, as the company responsible for the recall. It confirms distribution across the nation for the affected eye-care products and assigns the event number 99712.
This 2026 recall follows prior FDA review of Sterling’s Dupo facilities, although it is a separate regulatory action. In September 2022, the FDA issued Sterling a warning letter following an inspection earlier that year. The letter cited deficiencies in manufacturing practices involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current Walgreens eye drops recall pertains to sterility assurance based on a more recent FDA inspection. AvKare’s notice from 2026 indicates that Sterling found no confirmed sterility failures or product contamination.