DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall of nearly 748,000 eye-care items across the United States amid worries about sterility assurance. Among these, more than 500,000 packages are Walgreens-branded lubricant eye drops. The recall process started on Aug. 20 after issues emerged during a federal inspection. The U.S. Food and Drug Administration classified it as a Class II recall, which involves products that might cause temporary or medically reversible health effects, though serious health problems are considered unlikely.
Walgreens products make up the largest portion of the recall, with federal records listing 500,714 packages. This total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5%, a substance that helps alleviate burning and irritation caused by dry eyes. Distribution of the affected items was carried out by Walgreen Co. across the country. Several lots with expiration dates extending into 2027 are identified in the records.
The recall also affects products under various other brands and distributors. AvKare listings account for 120,241 twin packs of lubricant eye drops. Reliable-1 Laboratories products include 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Additional affected products are from Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records show that 747,844 units across nine product listings linked to Sterling Pharmaceutical Services are impacted.
Federal inspection prompted sterility concerns
AvKare stated that Sterling initiated the recall at the FDA’s request following observations made during a recent inspection. The findings involved manufacturing controls and aseptic processing, which are critical for preventing contamination in sterile drug production. AvKare emphasized that Sterling did not detect confirmed sterility failures or any evidence of contamination. The recall is described as a precautionary measure because the inspection findings affected sterility assurance. AvKare also advised customers to stop using the affected products.
Sterility controls are particularly vital for ophthalmic medicines because they are applied directly to the eyes. The FDA’s reason for the recall is the lack of assured sterility. Federal records specify lot numbers and expiration dates for each affected item. The recall encompasses Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals products. All are traced back to Sterling’s manufacturing facility in Dupo, Illinois.
Walgreens products constitute the majority of the recalled packages
Nearly two-thirds of all packages recalled are Walgreens lubricant eye drops. Lots of affected single bottles have expiration dates from September 2026 to June 2027. Twin-pack lots have expiration dates spanning from September 2026 to July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the recalling entity and show a nationwide distribution. The FDA assigned the recall event number 99712 as part of its official enforcement documentation.
This 2026 recall follows earlier federal scrutiny of Sterling’s Illinois facility, though it remains a separate regulatory issue. In September 2022, the FDA issued Sterling a warning letter after inspecting the plant earlier that year. The letter cited deficiencies in manufacturing practices related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall concerns sterility assurance following a more recent inspection. According to Sterling’s recall information provided by AvKare, no confirmed contamination or sterility failures have been identified.