DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has pulled back nearly 748,000 eye-care items across the country over worries related to sterility assurance. This recall involves more than 500,000 packages of Walgreens-branded lubricant eye drops. According to federal records, the company began the recall on Aug. 20. The U.S. Food and Drug Administration classified this as a Class II recall on Sept. 21, which pertains to products that might cause temporary or medically reversible health effects, with serious harm being unlikely.
Walgreens products account for 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 offer temporary relief from dry-eye symptoms such as burning, irritation, and discomfort. Walgreen Co. distributed these 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 product lines across various brands. AvKare’s lubricant eye drops account for 120,241 twin packs across two listings. Reliable-1 Laboratories’ items 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. In total, these human eye-care products amount to 747,844 units.
Recall initiated following FDA inspection findings
AvKare stated that Sterling launched the recall at the FDA’s request after observations made during a recent federal inspection. These observations involved manufacturing and aseptic processing controls, according to an Aug. 25 customer recall notice. The company emphasized that Sterling had not identified confirmed sterility failures or evidence of contamination. The notice described the action as precautionary since the inspection results could impact sterility assurance. Customers were instructed to cease using affected products immediately.
The FDA considers sterility a vital requirement for medicines applied directly to the eyes. Since ophthalmic products bypass some of the body’s natural defenses, maintaining sterile manufacturing and handling processes is crucial. The agency’s enforcement data points to the lack of sterility assurance as the reason behind the Sterling recall. Specific lot numbers and expiration dates for each affected product are listed in federal records. The recall affects products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens products make up the majority of the recalled units
About two-thirds of the total 747,844 packages subject to the recall are Walgreens lubricant eye drops. The affected single bottles include lots with expiration dates from September 2026 through June 2027, while the twin-pack lots have expiration dates from September 2026 through July 2027. The FDA enforcement record identifies Sterling Pharmaceutical Services of Dupo, Illinois, as the company responsible for the recall, with distribution across the entire country. The event is recorded as recall event number 99712.
This 2026 action follows previous FDA scrutiny of Sterling’s Dupo operations, though it is categorized as a separate regulatory event. In September 2022, the FDA issued Sterling a warning letter after an inspection earlier that year, citing deficiencies in manufacturing practices, contamination investigations, and aseptic processing controls concerning sterile ophthalmic products. The current Walgreens eye drops recall is based on sterility assurance issues identified during a more recent FDA inspection. AvKare’s 2026 notice states that Sterling found no confirmed sterility failure or contamination of the product.