DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has pulled back nearly 748,000 eye-care products across the country over concerns regarding sterility assurance. Included in this recall are over 500,000 packages branded by Walgreens for lubricant eye drops. The company announced the recall on Aug. 20, based on federal records. The U.S. Food and Drug Administration classified it as a Class II recall on Sept. 21, indicating products that might cause temporary or medically reversible health issues, with the potential for serious harm being unlikely.
Walgreens products make up 500,714 packages involved in the recall. 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 intended to provide short-term relief from burning, irritation, and discomfort caused by dry eyes. Walgreen Co. distributed these affected products nationwide. Federal records specify NDC 0363-8833-15 and list numerous impacted lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall encompasses nine different product listings across multiple brands. 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 applies to Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. Overall, the listed human eye-care items amount to 747,844 units.
Recall initiated following FDA inspection findings
AvKare stated that Sterling began the recall at the FDA’s request after observations made during a recent federal inspection. These findings concerned manufacturing and aseptic processing controls, according to an Aug. 25 customer recall notice. AvKare clarified that Sterling had not identified confirmed sterility failures or any evidence of product contamination. The notice described the recall as precautionary, noting that the inspection results could impact sterility assurance. Customers were advised to cease further use of the affected products.
The FDA considers sterility a vital requirement for medicines applied directly to the eyes. Ophthalmic products bypass some of the body’s natural defenses, making sterile manufacturing and handling especially important. The agency’s enforcement data cites lack of sterility assurance as the reason behind the Sterling recall. Federal records specify particular lot numbers and expiration dates for each affected item. The recall impacts products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Most recalled units are from Walgreens
Nearly two-thirds of the 747,844 packages subject to recall are Walgreens lubricant eye drops. The impacted single bottles from Walgreens include lots with expiration dates from September 2026 through June 2027. Twin-pack lots have expiration dates spanning September 2026 through July 2027. The FDA enforcement record lists Sterling Pharmaceutical Services of Dupo, Illinois, as the company responsible for the recall. It confirms distribution across the entire nation and assigns the event number 99712 to this recall.
This 2026 recall follows prior FDA scrutiny of Sterling’s Dupo operations, although it remains a separate regulatory incident. In September 2022, the FDA issued Sterling a warning letter after an inspection earlier that year. That letter cited deficiencies in manufacturing practices involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall for Walgreens eye drops concerns sterility assurance following a more recent FDA inspection. AvKare’s 2026 notice states Sterling detected no confirmed sterility failures or contamination in the affected products.
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