DUPO, ILLINOIS / RankWire.AI / – Nearly 748,000 eye-care products have been recalled across the country by Sterling Pharmaceutical Services due to concerns regarding sterility assurance. This recall encompasses more than 500,000 Walgreens-branded lubricant eye-drop packages. The company initiated the recall on Aug. 20, as recorded in federal documents. On Sept. 21, the U.S. Food and Drug Administration classified the action as a Class II recall, which involves products that may cause temporary or medically reversible health effects, with the risk of serious harm being considered unlikely.
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. The affected products contain carboxymethylcellulose sodium 0.5% and are used to temporarily soothe dry-eye symptoms such as burning, irritation, and discomfort. Walgreen Co. distributed these items nationwide. Federal records specify NDC 0363-8833-15 and list multiple affected lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall involves nine product listings from various brands. Among these, AvKare lubricant eye drops account for 120,241 twin packs 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. In total, these human eye-care products sum up to 747,844 units.
Recall triggered by FDA inspection outcomes
AvKare indicated that Sterling started the recall following the FDA’s request after findings during a recent federal inspection. These findings 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 emphasized that the recall was precautionary, as the inspection results could impact sterility assurance. Customers were advised to discontinue use of the affected products.
FDA regulations consider sterility a vital requirement for medicines administered directly to the eyes. Since ophthalmic products can bypass some of the body’s natural defenses, maintaining sterile manufacturing and handling processes is crucial. The FDA’s enforcement data cites lack of sterility assurance as the reason behind the Sterling recall. Specific lot numbers and expiration dates are listed in federal records for each affected product. The recall affects 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 units under recall are Walgreens lubricant eye drops, accounting for about two-thirds of the total. The affected single bottles have expiration dates from September 2026 to June 2027, while the twin-pack lots are valid through September 2026 to July 2027. The FDA enforcement record names Sterling Pharmaceutical Services of Dupo, Illinois, as the manufacturer responsible for the recall. It notes that distribution was nationwide and assigns the recall event number 99712.
This 2026 recall follows prior FDA scrutiny of Sterling’s Dupo operations, though it is a separate regulatory action. In September 2022, the FDA issued a warning letter to Sterling after an inspection earlier that year. That letter highlighted manufacturing practice deficiencies involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall of Walgreens eye drops concerns sterility assurance after a recent FDA inspection. AvKare’s notice from 2026 states that Sterling found no confirmed sterility failure or contamination of the products.