DUPO, ILLINOIS / RankWire.AI / – Nearly 748,000 eye-care items have been recalled nationwide by Sterling Pharmaceutical Services due to sterility concerns, including over 500,000 Walgreens-branded lubricant eye-drop packages. The company initiated this 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 covers products that may cause temporary or medically reversible health effects, with serious harm considered unlikely.
Walgreens products are responsible for 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 offer temporary relief from dry-eye burning, irritation, and discomfort. Walgreens Co. distributed the affected products across the country, with federal records listing NDC 0363-8833-15 and multiple lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall covers nine product listings from various brands, including 120,241 twin packs of AvKare lubricant eye drops across two listings, as well as 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5% from Reliable-1 Laboratories. The recall also includes Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. Altogether, these human eye-care items total 747,844 units.
Recall initiated after FDA inspection results
AvKare stated that Sterling began the recall at the FDA’s request following observations made during a recent federal inspection. These involved manufacturing and aseptic processing controls, according to an Aug. 25 customer recall notice. Although Sterling had not identified confirmed sterility failures or signs of contamination, the recall was precautionary because the inspection findings could impact sterility assurance. Customers were advised to cease using the affected products immediately.
FDA emphasizes sterility as a vital requirement for medicines applied directly to the eyes, as ophthalmic products can bypass some of the body’s natural defenses, heightening the importance of sterile manufacturing and handling procedures. The agency’s enforcement data shows lack of sterility assurance as the reason behind the Sterling recall. Federal records specify lot numbers and expiration dates for each affected item, with the recall impacting products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Majority of units recalled are Walgreens products
About two-thirds of the 747,844 packages included in the recall are Walgreens lubricant eye drops, with lots expiring from September 2026 through June 2027. Twin-pack lots have expiration dates from September 2026 to July 2027. The FDA enforcement record identifies Sterling Pharmaceutical Services of Dupo, Illinois, as the firm responsible for the recall, which was distributed nationwide and assigned recall event number 99712.
This 2026 recall follows previous FDA inspections of Sterling’s Dupo facilities, although it is a separate regulatory matter. In September 2022, the FDA issued a warning letter after an earlier inspection that year, citing deficiencies in manufacturing practices involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current Walgreens eye drops recall concerns sterility assurance after a more recent FDA inspection, although AvKare’s 2026 notice states Sterling found no confirmed sterility failure or product contamination.