DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall of nearly 748,000 eye-care products across the country due to issues related to sterility assurance. Among these, over 500,000 packages with Walgreens branding are affected. The company announced the recall on Aug. 20, according to federal records. The U.S. Food and Drug Administration classified this as a Class II recall on Sept. 21, a category designated for products that may cause temporary or medically reversible health effects, with the potential for serious harm considered unlikely.
Walgreens products comprise 500,714 of the affected packages, including 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5% and are used to temporarily relieve symptoms such as burning, irritation, and discomfort caused by dry eyes. Distribution was handled nationwide by Walgreen Co. Federal records specify NDC 0363-8833-15 and list multiple affected lots with expiration dates extending into 2027.
This broader recall by Sterling Pharmaceutical Services encompasses nine different product listings across various brands. AvKare’s lubricant eye drops account for 120,241 twin packs divided among 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. In total, all listed human eye-care items amount to 747,844 units.
Recall initiated following FDA inspection observations
AvKare stated that Sterling prompted the recall at the FDA’s request after findings during a recent federal inspection. These findings involved manufacturing processes and aseptic processing controls, as detailed in an Aug. 25 customer recall notice. According to the notice, Sterling had not identified confirmed sterility failures or indications of product contamination. The recall was characterized as precautionary, since the inspection results could impact sterility assurance. Customers were advised to cease using the affected products immediately.
FDA regulations emphasize sterility as an essential requirement for medicines administered directly to the eyes. Since ophthalmic products can bypass some natural defenses, maintaining sterile manufacturing and handling processes is crucial. The agency’s enforcement records cite lack of sterility assurance as the primary reason for the Sterling recall. Specific lot numbers and expiration dates for each affected item are listed in federal records. The recall affects products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens products constitute the majority of units recalled
Nearly two-thirds of the total 747,844 packages involved in the recall are Walgreens lubricant eye drops. The affected single-bottle lots have expiration dates from September 2026 through June 2027, while twin-pack lots range from September 2026 to July 2027. The FDA enforcement documentation names Sterling Pharmaceutical Services of Dupo, Illinois, as the company responsible for the recall. Distribution was nationwide, and the recall event is numbered 99712.
This 2026 recall follows prior FDA scrutiny of Sterling’s Dupo facility, though it represents a separate regulatory action. In September 2022, the FDA issued Sterling a warning letter following an inspection conducted earlier that year. The letter highlighted deficiencies in manufacturing practices related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current Walgreens eye drops recall concerns sterility assurance, based on findings from a more recent FDA inspection. AvKare’s 2026 notice confirms Sterling did not identify any confirmed sterility failure or contamination in its products.