DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a nationwide withdrawal of nearly 748,000 eye-care products over safety concerns related to sterility assurance. The recall specifically targets over 500,000 packages of Walgreens-branded lubricant eye drops. The company announced the recall on Aug. 20, as recorded in federal documents. The U.S. Food and Drug Administration (FDA) classified it as a Class II recall on Sept. 21, indicating that the products might cause temporary or reversible health issues, with the likelihood of serious harm being low.
Walgreens products make up 500,714 of the packages involved. 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 intended to provide temporary relief from symptoms of dry-eye burning, irritation, and discomfort. Walgreen Co. distributed these affected items across the entire country. 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 product listings from various brands. Among them, AvKare lubricant eye drops account for 120,241 twin packs across two listings. Reliable-1 Laboratories’ affected products include 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. Altogether, these human eye-care items total 747,844 units.
Recall prompted by FDA inspection results
AvKare stated that Sterling initiated the recall at the FDA’s request after observations made during a recent federal inspection. The findings involved manufacturing processes and aseptic handling procedures, according to an Aug. 25 customer recall notice. AvKare clarified that Sterling had not identified confirmed failures in sterility or signs of contamination. The recall was described as a precautionary measure because the inspection findings could potentially impact sterility assurance. Customers were advised to cease using the affected products immediately.
FDA regulations emphasize sterility as an essential requirement for medicines intended for direct application to the eyes. Since ophthalmic products can bypass some natural defenses of the eye, maintaining sterile manufacturing and handling conditions is crucial. The agency’s enforcement records cite a lack of sterility assurance as the reason behind Sterling’s recall. Specific lot numbers and expiration dates are listed for each affected product. This recall impacts products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens products constitute the majority of the recalled units
The majority of the 747,844 packages subject to recall are Walgreens lubricant eye drops, accounting for approximately two-thirds of the total. The affected bottles carry lot numbers with expiration dates ranging from September 2026 to June 2027, while twin-pack lots have expiration dates from September 2026 through July 2027. The FDA enforcement record identifies Sterling Pharmaceutical Services based in Dupo, Illinois, as the company responsible for the recall. The affected products were distributed across the country, and the recall event is numbered 99712.
This 2026 recall follows prior scrutiny by the FDA of Sterling’s Dupo facility, although it is considered a separate regulatory event. In September 2022, the FDA issued Sterling a warning letter after an inspection earlier that year. That letter cited deficiencies in manufacturing practices, including issues related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall of Walgreens eye drops concerns sterility assurance following a more recent FDA inspection, although AvKare’s notice states that Sterling found no confirmed sterility failures or contamination issues.