DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall of nearly 748,000 eye-care products across the country amid sterility assurance concerns. The recall specifically affects over 500,000 packages of Walgreens-branded lubricant eye-drops. The company announced the recall on Aug. 20, according to federal records. The U.S. Food and Drug Administration classified this action as a Class II recall on Sept. 21, indicating products that could cause temporary or medically reversible health effects, with serious harm deemed unlikely.
Walgreens items make up 500,714 packages in the recall, including 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5% and are intended to temporarily soothe dry-eye symptoms such as burning, irritation, and discomfort. Walgreen Co. distributed the affected items nationwide. Federal records specify NDC 0363-8833-15 and detail multiple lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall involves nine product listings across various brands. Among these, AvKare lubricant eye drops account for 120,241 twin packs across two listings. Reliable-1 Laboratories products include 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5%. The recall also covers Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. Collectively, the affected human eye-care products total 747,844 units.
Recall initiated following FDA inspection findings
AvKare stated that Sterling began the recall at the FDA’s request after observations made during a recent federal inspection. The issues involved manufacturing and aseptic processing controls, according to an Aug. 25 customer recall notice. AvKare emphasized that Sterling had not identified confirmed sterility failures or evidence of contamination. The notice described the recall as precautionary, given that the inspection findings could impact sterility assurance. Customers were advised to cease using the affected products immediately.
The FDA considers sterility a vital requirement for medicines applied directly to the eyes. Because ophthalmic products can bypass some of the body’s defenses, maintaining sterile manufacturing and handling practices is especially critical. The agency’s enforcement data highlights lack of sterility assurance as the reason behind the Sterling recall. Federal records list specific lot numbers and expiration dates for each affected product, which include items from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens products constitute the majority of recalled units
Approximately two-thirds of the 747,844 packages covered in the 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 from September 2026 to July 2027. The FDA enforcement record names Sterling Pharmaceutical Services of Dupo, Illinois, as the entity responsible for the recall. It confirms the nationwide distribution of the affected products and assigns the recall event number 99712.
This 2026 recall follows prior FDA scrutiny of Sterling’s Dupo operations, although it is a separate regulatory event. In September 2022, the FDA issued Sterling a warning letter after an inspection earlier that year. The letter cited manufacturing deficiencies related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current Walgreens eye drops recall concerns sterility assurance following a more recent FDA inspection. AvKare’s 2026 notice states that Sterling found no confirmed sterility failure or contamination of the products.