DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has recalled nearly 748,000 eye-care products nationwide over concerns about sterility assurance. The recall includes more than 500,000 Walgreens-branded lubricant eye-drop packages. Sterling initiated the recall on Aug. 20, according to federal records. The U.S. Food and Drug Administration classified it as a Class II recall on Sept. 21. That category covers products that may cause temporary or medically reversible health effects, with serious harm considered remote.
Walgreens products account for 500,714 packages in the recall. That total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. The products contain carboxymethylcellulose sodium 0.5% and provide temporary relief from dry-eye burning, irritation and discomfort. Walgreen Co. distributed the affected products nationwide. Federal records identify NDC 0363-8833-15 and list multiple affected lots with expiration dates extending into 2027.
The wider Sterling Pharmaceutical Services recall covers nine product listings across several brands. 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 action also covers Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops and Major LubriFresh P.M. Nighttime Ointment. Together, the listed human eye-care products total 747,844 units.
Recall followed FDA inspection findings
AvKare said Sterling initiated the recall at the FDA’s request after observations during a recent federal inspection. Those observations involved manufacturing and aseptic processing controls, according to an Aug. 25 customer recall notice. AvKare said Sterling had not identified confirmed sterility failures or evidence of product contamination. The notice described the action as precautionary because the inspection findings could affect assurance of sterility. AvKare instructed customers to stop further use of its affected product.
The FDA treats sterility as a critical requirement for medicines applied directly to the eyes. Ophthalmic products can bypass some of the body’s natural defenses, increasing the importance of sterile manufacturing and handling. The agency’s enforcement information identifies lack of assurance of sterility as the reason for the Sterling recall. Federal records list specific lot numbers and expiration dates for each affected product. The recall spans Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP and Major Pharmaceuticals products.
Walgreens products account for most recalled units
Walgreens lubricant eye drops represent about two-thirds of the 747,844 packages covered by the recall. The affected Walgreens single bottles include lots with expiration dates from September 2026 through June 2027. Twin-pack lots carry expiration dates ranging from September 2026 through July 2027. The FDA enforcement record identifies Sterling Pharmaceutical Services of Dupo, Illinois, as the recalling firm. It lists nationwide distribution for the affected eye-care products and assigns the recall event number 99712.
The 2026 action follows previous FDA scrutiny of Sterling’s Dupo operations, although it represents a separate regulatory event. In September 2022, the FDA issued Sterling a warning letter after an inspection earlier that year. That letter cited manufacturing practice deficiencies involving 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 product contamination.