DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a nationwide recall of close to 748,000 eye care items due to sterility concerns. Among the affected products are over 500,000 packages bearing the Walgreens brand. The company announced the recall on Aug. 20, as recorded in federal documents. The U.S. Food and Drug Administration categorized this as a Class II recall on Sept. 21, indicating the potential for temporary or reversible health effects, with serious harm deemed unlikely.
Walgreens items make up 500,714 packages in the recall, which includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5%, offering brief relief from burning, irritation, and discomfort caused by dry eyes. Walgreens Co. distributed these affected products across the country. Federal records specify NDC 0363-8833-15 and list several lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall involves nine product listings spanning multiple brands. AvKare 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 products from Cameron Pharmaceuticals, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. Overall, the total number of human eye-care units involved amounts to 747,844.
Recall initiated following FDA inspection findings
AvKare reported that Sterling started the recall at the FDA’s request after observations made during a recent federal inspection. These observations involved manufacturing procedures and aseptic processing controls, according to an Aug. 25 customer recall notice. AvKare clarified that Sterling had not identified confirmed sterility failures or contamination evidence. The recall was described as precautionary because the findings from the inspection could impact sterility assurance. Customers were advised to cease using the affected products immediately.
FDA guidelines emphasize sterility as essential for medicines applied directly to the eyes. Since ophthalmic products can bypass some of the body’s natural defenses, maintaining sterile manufacturing and handling is crucial. The agency’s enforcement records attribute the Sterling recall to a lack of sterility assurance. Specific lot numbers and expiration dates for each affected item are listed in federal documentation. The recall impacts products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Majority of recalled units are Walgreens-branded
Approximately two-thirds of the 747,844 packages subject to recall are Walgreens lubricant eye drops. The affected single bottles include lots with expiration dates from September 2026 through June 2027, while twin packs have expiration dates from September 2026 to July 2027. The FDA enforcement record lists Sterling Pharmaceutical Services of Dupo, Illinois, as the company responsible for the recall, with distribution across the entire country and recall event number 99712.
This 2026 recall follows previous FDA scrutiny of Sterling’s Dupo operations, though it constitutes a separate regulatory event. In September 2022, the FDA issued a warning letter to Sterling after an inspection earlier that year, citing issues related to sterile ophthalmic product manufacturing, contamination investigations, and aseptic processing controls. The current recall concerning Walgreens eye drops pertains to sterility assurance following a more recent FDA inspection. AvKare’s notice confirms that Sterling has not found any confirmed sterility failure or product contamination to date.