DUPO, ILLINOIS / RankWire.AI / – In Sterling, Illinois, on August 20, Sterling Pharmaceutical Services launched a recall of nearly 748,000 eye-care products across the country because of sterility assurance issues. This recall notably includes over 500,000 packages of Walgreens-branded lubricant eye drops. According to federal records, the company initiated the recall, which the U.S. Food and Drug Administration classified as a Class II recall on September 21. This category is designated for products that may cause temporary or medically reversible health effects, with serious harm deemed unlikely.
Walgreens products included in the recall comprise 500,714 packages, which consist of 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5% and are intended to temporarily relieve symptoms like burning, irritation, and discomfort caused by dry eyes. The affected items were distributed nationwide by Walgreen Co. Federal records specify NDC 0363-8833-15 and list multiple lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall involves nine product listings across various brands. Among them, AvKare lubricant eye drops account for 120,241 twin packs spread 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 recall also covers Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment, bringing the total affected units to 747,844.
Recall initiated following FDA inspection results
AvKare stated that Sterling triggered the recall at the FDA’s request following observations made during a recent federal inspection. These observations concerned manufacturing practices 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 product contamination. The notice described the move as precautionary, as the inspection findings could impact sterility assurance. Customers were advised to cease using the affected products immediately.
FDA regulations emphasize the critical importance of sterility for medicines applied directly to the eyes. Ophthalmic products bypass some of the body’s natural defenses, heightening the need for sterile manufacturing and handling. The FDA’s enforcement records cite lack of sterility assurance as the reason for the Sterling recall. These records specify particular lot numbers and expiration dates for each affected product. 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
Nearly two-thirds of the total 747,844 packages subject to recall are Walgreens lubricant eye drops. The affected single bottles include lots with expiration dates ranging from September 2026 to June 2027. Twin-pack lots have expiration dates from September 2026 through July 2027. Federal records list Sterling Pharmaceutical Services of Dupo, Illinois, as the company responsible for the recall. These products were distributed nationwide, with the event assigned number 99712.
This 2026 recall follows previous FDA scrutiny of Sterling’s Dupo operations, although it constitutes a separate regulatory event. In September 2022, the FDA issued Sterling a warning letter after an inspection earlier that year. The letter cited deficiencies in manufacturing practices involving 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. AvKare’s 2026 notice emphasizes that Sterling found no confirmed sterility failure or product contamination.