DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall of nearly 748,000 eye-care products across the country because of concerns related to sterility assurance. Among those affected are more than 500,000 packages branded by Walgreens. The recall was initiated by Sterling on Aug. 20, according to federal records. On Sept. 21, the U.S. Food and Drug Administration classified it as a Class II recall, which typically involves products that may cause temporary or reversible health effects, with the likelihood of serious harm being remote.
Walgreens products make up 500,714 packages in this recall. This total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5% and are designed to provide temporary relief from dry-eye symptoms such as burning, irritation, and discomfort. Walgreen Co. distributed the affected items nationwide. Federal records specify NDC 0363-8833-15 and list multiple lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall encompasses nine different product listings across various brands. AvKare lubricant eye drops account for 120,241 twin packs across two listings. Reliable-1 Laboratories includes 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5%. The recall also involves Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. All together, the affected human eye-care products total 747,844 units.
Recall follows findings from FDA inspections
AvKare stated that Sterling initiated the recall at the FDA’s request following observations during a recent federal inspection. These observations 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 signs of product contamination. The recall was described as precautionary because the inspection findings could impact sterility assurance. Customers were advised to cease using the affected products immediately.
FDA regulations emphasize sterility as a vital requirement for medicines applied directly to the eyes. Since ophthalmic products can bypass some of the body’s natural defenses, sterile manufacturing and handling are crucial. The FDA’s enforcement data lists lack of sterility assurance as the primary reason for the Sterling recall. Specific lot numbers and expiration dates are included in federal records for each affected product. The recall covers products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens products constitute the majority of the recalled units
About two-thirds of the 747,844 packages subject to recall are Walgreens lubricant eye drops. The affected bottles from Walgreens carry expiration dates from September 2026 through June 2027. The twin-pack lots list expiration dates from September 2026 through July 2027. Federal enforcement records identify Sterling Pharmaceutical Services of Dupo, Illinois, as the company responsible for the recall. They also specify that the affected products were distributed nationwide and assign the recall event number 99712.
This 2026 recall follows previous FDA inspections of Sterling’s Dupo operations, although it is a separate regulatory action. In September 2022, the FDA issued Sterling a warning letter after an earlier inspection that year. That letter cited deficiencies in manufacturing practices 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. According to AvKare’s 2026 notice, Sterling has not identified any confirmed sterility failures or contamination issues in these products.