DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has recalled nearly 748,000 eye-care items across the country amid worries related to sterility assurance. The recall encompasses more than 500,000 packages of Walgreens-branded lubricant eye drops. The company announced the recall on Aug. 20, according to federal records. On Sept. 21, the U.S. Food and Drug Administration classified the recall as a Class II event. This classification includes products that could cause temporary or medically reversible health effects, with serious harm considered unlikely.
Walgreens products make up 500,714 packages in the recall. This total comprises 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These items contain carboxymethylcellulose sodium 0.5% and offer temporary relief from symptoms such as dry-eye burning, irritation, and discomfort. Walgreen Co. distributed the affected products nationwide. Federal documentation lists NDC 0363-8833-15 and details multiple lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall covers nine product listings across various brands. Among them, AvKare lubricant eye drops account for 120,241 twin packs over 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%. Additional products include Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. All together, these human eye-care products total 747,844 units.
Recall issued following FDA inspection results
AvKare explained that Sterling initiated the recall at the FDA’s request after observations made during a recent federal inspection. These involved manufacturing processes and aseptic processing controls, according to an Aug. 25 customer recall notice. AvKare clarified that Sterling had not identified confirmed sterility failures or evidence of contamination. The notice described the action as precautionary because the inspection findings could impact sterility assurance. Customers were instructed to cease further use of the affected products.
The FDA emphasizes sterility as a critical factor for medicines applied directly to the eyes. Ophthalmic products bypass some of the body’s natural defenses, which heightens the necessity for sterile manufacturing and handling. The agency’s enforcement records specify that lack of sterility assurance is the reason behind the Sterling recall. Details include lot numbers and expiration dates for each impacted product. The recall affects 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 total 747,844 packages recalled are Walgreens lubricant eye drops. The affected single bottles feature lots with expiration dates from September 2026 through June 2027. Twin-pack lots have expiration dates spanning from September 2026 to July 2027. According to the FDA enforcement record, Sterling Pharmaceutical Services of Dupo, Illinois, is responsible for the recall. The affected products were distributed nationwide, with the recall event number listed as 99712.
This 2026 recall follows prior FDA scrutiny of Sterling’s operations in Dupo, although it is a separate regulatory matter. In September 2022, the FDA issued Sterling a warning letter following an inspection earlier that year. That document cited manufacturing practice deficiencies related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current Walgreens eye drops recall pertains to sterility assurance following a more recent FDA inspection. AvKare’s 2026 notice states that Sterling found no confirmed sterility failure or contamination in its products.