DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall for nearly 748,000 eye-care products nationwide due to sterility concerns. This action includes over 500,000 Walgreens-branded lubricant eye-drop packages. The recall was initiated on Aug. 20 after issues were identified during a federal inspection. The U.S. Food and Drug Administration classified it as a Class II recall. This classification applies to products that might cause temporary or reversible health effects, with serious health consequences being unlikely.
Walgreens products constitute the largest portion of the recall, with 500,714 packages listed in federal records. This includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5%, which provides relief from burning and irritation caused by dry eyes. Walgreen Co. distributed the affected items across the United States. Records specify several lots with expiration dates extending into 2027.
The recall also impacts products sold 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. Additionally, products from Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals are involved. Federal records show a total of 747,844 affected units across nine product listings linked to Sterling Pharmaceutical Services.
Inspection by federal authorities raised sterility worries
AvKare reported that Sterling began the recall at the FDA’s request following a recent inspection. The findings concerned manufacturing controls and aseptic processing, which are crucial for keeping sterile drug products free from contamination. AvKare stated that Sterling had not found confirmed sterility failures or signs of contamination. The recall was described as precautionary, as the inspection results affected sterility assurance. AvKare also advised customers to stop using the affected products.
Sterility is especially important for ophthalmic medicines because they are applied directly to the eyes. The FDA explains that the reason for this recall is the lack of assurance regarding sterility. Federal records detail each affected product’s lot numbers and expiration dates. The recall includes items from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. All originate from Sterling’s manufacturing facility in Dupo, Illinois.
Most of the recalled packages are Walgreens products
Walgreens eye drops make up about two-thirds of all packages recalled. The affected single-bottle lots have expiration dates from September 2026 to June 2027. Twin-pack lots have expiration dates from September 2026 to July 2027. Federal records identify Sterling Pharmaceutical Services as the company responsible for the recall. The products were distributed nationwide. The FDA assigned recall event number 99712 to this case as part of its official enforcement documentation.
This 2026 recall follows previous federal scrutiny of Sterling’s Illinois facility, although it remains a separate matter. In September 2022, the FDA issued Sterling a warning letter after inspecting the plant earlier that year. The letter cited deficiencies in manufacturing practices for sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall concerns sterility assurance after a more recent inspection. According to AvKare, Sterling’s recall details indicate no confirmed contamination or sterility failures have been detected.