DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall for close to 748,000 eye-care products nationwide due to concerns regarding sterility assurance. This recall involves over 500,000 packages of Walgreens-branded lubricant eye drops. The company initiated the recall on Aug. 20 after issues were identified during a federal inspection. The U.S. Food and Drug Administration classified the recall as a Class II action, indicating that the products could cause temporary or medically reversible health effects, though serious health outcomes are unlikely.
Walgreens products constitute the largest portion of the recall, with 500,714 packages documented 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 alleviates burning and irritation associated with dry eyes. Distributing the affected items across the U.S., Walgreen Co. has identified several lots with expiration dates extending into 2027.
The recall also encompasses products marketed under various other brands and by different distributors. AvKare accounts for 120,241 twin packs of lubricant eye drops. Reliable-1 Laboratories’ affected items include 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Additional affected products are listed under Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records confirm a total of 747,844 units impacted across nine product lines linked to Sterling Pharmaceutical Services.
Federal inspection raised sterility concerns
AvKare stated that Sterling initiated the recall following a FDA’s request after a recent inspection identified issues related to manufacturing controls and aseptic processing—methods used to prevent contamination in sterile drug production. Although Sterling had not discovered confirmed sterility failures or contamination, AvKare described the recall as a precautionary measure because the inspection raised concerns over sterility assurance. Customers were advised to cease using the affected products.
Sterility is particularly critical for ophthalmic medicines since they are applied directly to the eyes. The FDA explains that the current recall is driven by a lack of assurance regarding sterility. Federal records specify lot numbers and expiration dates for each product involved. The scope covers Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals products, all traced back to Sterling’s manufacturing facility in Dupo, Illinois.
Most packages affected are Walgreens-branded
Approximately two-thirds of the recalled packages are Walgreens eye drops. The impacted single-bottle lots have expiration dates from September 2026 to June 2027, while twin-pack lots are valid from September 2026 through July 2027. Federal enforcement records list Sterling Pharmaceutical Services as the responsible company, with the recall distributed nationwide. The FDA assigned event number 99712 to this recall as part of its official record.
This 2026 recall follows prior federal scrutiny of Sterling’s Illinois facility, although it remains a separate regulatory matter. In September 2022, the FDA issued Sterling a warning letter after inspecting the plant earlier that year, citing deficiencies in sterile ophthalmic product manufacturing, contamination investigations, and aseptic processing controls. The current recall relates to sterility assurance following a recent inspection. Sterling’s recall details, as provided by AvKare, indicate no confirmed contamination or sterility failures had been identified at that time.