DUPO, ILLINOIS / RankWire.AI / – In the United States, Sterling Pharmaceutical Services announced a recall on August 20 of nearly 748,000 eye-care products nationwide, citing concerns related to sterility assurance. The recall notably includes more than 500,000 packages of Walgreens-branded lubricant eye drops. The action was initiated following issues uncovered during a federal inspection, leading the U.S. Food and Drug Administration to classify the recall as Class II. This classification pertains to products that could result in temporary or medically reversible health effects, while serious health consequences are considered unlikely.
Walgreens products account for the largest portion of the recalled items, with 500,714 packages documented in federal records. This total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. The products contain carboxymethylcellulose sodium 0.5%, a substance that helps alleviate burning and irritation associated with dry eyes. Distribution of these affected items was carried out across the United States by Walgreen Co., and records specify several affected lots with expiration dates extending into 2027.
The recall also encompasses items sold under multiple other brands and distributors. For instance, AvKare listings account for 120,241 twin packs of lubricant eye drops. Products from Reliable-1 Laboratories include 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Additional affected products are associated with Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records show a total of 747,844 units impacted across nine product listings linked to Sterling Pharmaceutical Services.
Federal inspection raised sterility concerns
AvKare stated that Sterling initiated the recall at the FDA’s request following observations made during a recent inspection. These findings involved manufacturing controls and aseptic processing—critical procedures used to prevent contamination of sterile drug products. AvKare emphasized that Sterling had not identified confirmed sterility failures or evidence of contamination. The company described the recall as a precautionary measure, noting that the inspection findings impacted sterility assurance. Customers were advised to cease using the affected products from AvKare.
Sterility is especially crucial for ophthalmic medicines since they are applied directly to the eyes. The FDA has cited the lack of sterility assurance as the reason behind the current recall. Federal records detail specific lot numbers and expiration dates for each impacted product. This recall involves Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals products, all traced back to Sterling’s manufacturing plant in Dupo, Illinois.
Walgreens products constitute the majority of the recalled packages
Nearly two-thirds of the total packages under recall are Walgreens lubricant eye drops. The affected single-bottle lots carry expiration dates from September 2026 through June 2027, while the twin-pack lots range from September 2026 to July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the recalling company and indicate distribution across the country. The FDA’s formal enforcement record assigns the recall event number 99712.
This 2026 recall follows earlier federal investigations into Sterling’s Illinois facility, although it is a separate regulatory action. In September 2022, the FDA issued Sterling a warning letter after inspecting the plant earlier that year. The letter cited deficiencies related to manufacturing practices involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall focuses on sterility assurance issues found during a more recent inspection. According to Sterling’s recall details relayed by AvKare, no confirmed contamination or sterility failures have been identified at this time.