DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall of nearly 748,000 eye-care items across the country over sterility assurance issues. Among these, more than 500,000 packages branded by Walgreens are affected. The recall was launched on Aug. 20, as reported in federal records. The U.S. Food and Drug Administration classified it as a Class II recall on Sept. 21, indicating products that could cause temporary or medically reversible health effects, with the possibility of serious harm being remote.
Walgreens products make up 500,714 packages in this recall, which includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5% and are used for temporary relief from dry-eye symptoms such as burning, irritation, and discomfort. Distribution across the nation was managed by Walgreen Co. Federal records specify NDC 0363-8833-15 and list numerous lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall encompasses nine different product listings across multiple brands. For instance, AvKare lubricant eye drops account for 120,241 twin packs spread over two listings, while Reliable-1 Laboratories includes 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5%. The recall also involves Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. In total, these human eye-care products amount to 747,844 units.
Recall Initiated Following FDA Inspection Results
AvKare stated that Sterling began the recall at the FDA’s request after observations during a recent federal inspection. These observations related to manufacturing practices and aseptic processing controls, according to an Aug. 25 customer recall notice. The company emphasized that Sterling had not identified confirmed sterility failures or evidence of product contamination. The notice described the recall as precautionary, as the inspection findings could impact sterility assurance. Customers were advised to cease using the affected products immediately.
FDA regulations regard sterility as a vital requirement for medicines applied directly to the eyes. Because ophthalmic products can bypass the body’s natural defenses, maintaining sterile manufacturing and handling processes is critical. The agency’s enforcement records specify that the Sterling recall was prompted by concerns over sterility assurance. These records list precise lot numbers and expiration dates for each affected item. The recall impacts products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Majority of Units Recalled Are Walgreens Products
Almost two-thirds of the 747,844 packages involved in the recall are Walgreens lubricant eye drops. The affected single bottles from Walgreens include lots with expiration dates from September 2026 through June 2027. Twin-pack lots carry expiration dates ranging from September 2026 to July 2027. The enforcement record from the FDA lists Sterling Pharmaceutical Services of Dupo, Illinois, as the entity responsible for the recall. It confirms nationwide distribution of these eye-care products and assigns the event number 99712 to the recall.
This 2026 recall follows prior FDA investigations into Sterling’s Dupo facilities, though it constitutes a separate regulatory action. In September 2022, the FDA issued Sterling a warning letter following an inspection earlier that year. That letter identified manufacturing practice deficiencies, including issues with sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current Walgreens eye drops recall, concerning sterility assurance, is based on findings from a more recent FDA inspection. AvKare’s 2026 notice clarified that Sterling had not identified confirmed sterility failures or product contamination.