DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall of nearly 748,000 eye-care products across the country over safety concerns related to sterility assurance. Included in this recall are more than 500,000 packages of Walgreens-branded lubricant eye drops. The recall was launched on Aug. 20, as recorded in federal documentation. The U.S. Food and Drug Administration categorized it as a Class II recall on Sept. 21, a classification that pertains to products that might cause temporary or medically reversible health effects, with the risk of serious harm being remote.
Walgreens products make up 500,714 packages in this recall, which 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 dry-eye symptoms such as burning, irritation, and discomfort. 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 encompasses nine product listings across various brands. Among these, 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. In total, these human eye-care items amount to 747,844 units.
Recall prompted by FDA inspection results
AvKare stated that Sterling initiated the recall at the FDA’s request following observations made during a recent federal inspection. These observations involved 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 contamination. The notice described the recall as precautionary, noting that the inspection findings could impact sterility assurance. Customers were advised to cease further use of the affected products.
FDA regulations emphasize sterility as a vital aspect for medicines applied directly to the eyes. Because ophthalmic products can bypass some of the body’s natural defenses, sterile manufacturing and handling are of utmost importance. The agency’s enforcement records cite lack of sterility assurance as the reason behind the Sterling recall. Specific lot numbers and expiration dates are listed for each affected item. The recall impacts products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Majority of recalled units are from Walgreens
Approximately two-thirds of the 747,844 packages subject to recall are Walgreens lubricant eye drops. The affected single bottles are from lots with expiration dates spanning from September 2026 to June 2027. 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. The products were distributed nationwide, and the recall event number assigned is 99712.
This 2026 recall follows prior FDA oversight of Sterling’s Dupo operations, although it is a separate regulatory matter. In September 2022, the FDA issued Sterling a warning letter after an earlier inspection conducted that year. The letter highlighted deficiencies in manufacturing practices involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall of Walgreens eye drops is related to sterility assurance following a more recent FDA inspection. According to AvKare’s 2026 notice, Sterling found no confirmed sterility failures or product contamination.