DUPO, ILLINOIS / RankWire.AI / – In a broad recall announced recently, Sterling Pharmaceutical Services has pulled nearly 748,000 eye-care products from shelves across the country amid sterility safety worries. The recall specifically targets more than 500,000 packages branded under Walgreens. According to federal records, Sterling initiated this action on Aug. 20. The U.S. Food and Drug Administration designated it as a Class II recall on Sept. 21, indicating that the affected products could cause temporary or reversible health effects, with serious harm being unlikely.
Walgreens products comprise 500,714 of the affected packages. This total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These items contain carboxymethylcellulose sodium 0.5% and are used to temporarily alleviate symptoms such as dry-eye burning, irritation, and discomfort. Distribution of the impacted products was carried out nationwide by Walgreen Co. Federal documentation lists NDC 0363-8833-15 and specifies multiple lots with expiration dates extending into 2027.
The larger Sterling Pharmaceutical Services recall involves nine different product listings across several brands. For instance, AvKare’s lubricant eye drops account for 120,241 twin packs across two listings. Reliable-1 Laboratories’ line includes 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5%. The recall also covers products from Cameron Pharmaceuticals, TRP, and Major LubriFresh P.M., Nighttime Ointment. Overall, these human eye-care items amount to 747,844 units affected by the recall.
Recall triggered by FDA inspection findings
AvKare reported that Sterling initiated the recall following a request from the FDA after observations made during a recent federal inspection. According to an Aug. 25 customer recall notice, the inspection focused on manufacturing and aseptic processing controls. AvKare clarified that Sterling had not confirmed any sterility failures or evidence of contamination in the products. The company described the action as a precautionary measure, explaining that the inspection findings could impact sterility assurance. Customers were advised to cease using the affected products immediately.
FDA regulations emphasize sterility as essential for medicines administered directly to the eyes. Since ophthalmic products can bypass some of the body’s natural defenses, maintaining sterile manufacturing and handling procedures is crucial. The agency’s enforcement records cite lack of sterility assurance as the reason behind the Sterling recall. Specific lot numbers and expiration dates for each impacted item are listed in federal documents. 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
Nearly two-thirds of the 747,844 affected packages are Walgreens lubricant eye drops. The lots of individual bottles include expiration dates from September 2026 through June 2027. The twin-pack lots feature expiration dates from September 2026 to July 2027. According to the FDA enforcement record, Sterling Pharmaceutical Services of Dupo, Illinois, is identified as the company responsible for the recall. The affected products were distributed nationwide, and the event is recorded under recall number 99712.
This 2026 recall follows previous scrutiny by the FDA regarding Sterling’s Dupo operations, though it is a separate regulatory action. In September 2022, the FDA issued a warning letter after an earlier inspection that year, citing deficiencies in sterile manufacturing practices, contamination investigation procedures, and aseptic processing controls. The current Walgreens eye drops recall pertains to sterility assurance concerns identified during a more recent FDA inspection. AvKare’s notice states that Sterling found no confirmed sterility failures or contamination in the affected products.