DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a nationwide recall of nearly 748,000 eye-care products due to sterility assurance issues. The recall specifically involves over 500,000 packages branded by Walgreens. The company announced the recall on Aug. 20, as recorded in federal documents. On Sept. 21, the U.S. Food and Drug Administration classified it as a Class II recall. This category indicates products that could lead to temporary or medically reversible health effects, with the potential for serious harm considered unlikely.
Walgreens products make up 500,714 of the packages affected. 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 used for temporary relief from dry-eye symptoms such as burning, irritation, and discomfort. The affected products were distributed across the country by Walgreen Co. Federal records specify NDC 0363-8833-15 and list multiple lots with expiration dates extending into 2027.
The broader recall by Sterling Pharmaceutical Services encompasses nine product listings across various brands. Among these, AvKare lubricant eye drops account for 120,241 twin packs spread over two listings. Reliable-1 Laboratories has 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5%. The recall also includes products from Cameron Pharmaceuticals, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. In total, these human eye-care items amount to 747,844 units.
Recall initiated based on FDA inspection observations
AvKare reported that Sterling commenced the recall following the FDA’s request after findings during a recent federal inspection. These findings involved manufacturing and aseptic processing controls, according to an Aug. 25 customer recall notice. AvKare clarified that Sterling had not confirmed sterility failures or contamination evidence. The notice emphasized that the recall was precautionary, as the inspection results could impact sterility assurance. Customers were advised to cease using the affected products immediately.
The FDA considers sterility critical for medicines applied directly to the eyes. Since ophthalmic products can bypass some of the body’s natural defenses, ensuring sterile manufacturing and handling is vital. The agency’s enforcement data indicates that lack of sterility assurance prompted the Sterling recall. Federal records specify lot numbers and expiration dates for all impacted products, which include items from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Majority of recalled units are Walgreens products
Approximately two-thirds of the 747,844 packages subject to recall are Walgreens lubricant eye drops. The affected single bottles carry expiration dates from September 2026 through June 2027, while twin-pack lots have expiration dates ranging from September 2026 to July 2027. The FDA enforcement record names Sterling Pharmaceutical Services, located in Dupo, Illinois, as the company responsible for the recall. It confirms that the products were distributed nationwide and assigns the event number 99712.
This 2026 recall follows prior FDA scrutiny of Sterling’s Dupo operations, although it is a separate regulatory matter. In September 2022, the FDA issued Sterling a warning letter following an inspection earlier that year, citing manufacturing practice deficiencies involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current Walgreens eye drops recall relates to sterility assurance after a more recent FDA inspection. AvKare’s 2026 notice states that Sterling has not identified confirmed sterility failure or product contamination.