DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has initiated a recall of close to 748,000 eye-care products across the United States amid concerns related to sterility assurance. This recall notably includes over 500,000 packages of Walgreens-branded lubricant eye drops. The company began the voluntary recall on August 20 after issues emerged during an inspection conducted by federal authorities. The U.S. Food and Drug Administration subsequently classified it as a Class II recall, which applies to products that might cause temporary or medically reversible health effects, with serious health consequences being unlikely.
Walgreens products constitute the largest portion of the recall, with federal records listing 500,714 packages. Among these, 301,114 are bottles of Walgreens Lubricant Eye Drops, and 199,600 are twin packs. These products contain carboxymethylcellulose sodium 0.5%, an ingredient used to alleviate burning sensations and irritation associated with dry eyes. Distributing the affected items across the country, Walgreen Co. supplied the products with several lots expiring into 2027, according to official records.
The scope of the recall extends beyond Walgreens, encompassing products marketed under various other brands and distributors. For instance, AvKare’s listings account for 120,241 twin packs of lubricant eye drops, while Reliable-1 Laboratories’ affected stock includes 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 that Sterling Pharmaceutical Services is linked to a total of 747,844 impacted units across nine different product listings.
Federal inspection findings prompted sterility concerns
AvKare stated that Sterling initiated the recall at the FDA’s request following observations made during a recent inspection. These findings focused on manufacturing controls and aseptic processing, techniques crucial for preventing contamination in sterile drug production. AvKare clarified that Sterling had not confirmed any sterility failures or evidence of contamination, but the recall was deemed necessary as a precaution because the inspection raised questions about sterility assurance. The company also advised customers to immediately cease use of its affected products.
Because ophthalmic medications are applied directly to the eyes, maintaining sterility in these products is especially critical. The FDA emphasizes that the current recall is primarily due to concerns over sterility assurance. Each impacted product lot includes specific lot numbers and expiration dates, with affected items distributed to Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. All affected products trace back to Sterling’s manufacturing facility in Dupo, Illinois.
Majority of recalled packages are Walgreens-branded
The majority of the recalled eye drops are Walgreens-branded, accounting for approximately two-thirds of all affected packages. The lots with single bottles have expiration dates ranging from September 2026 to June 2027, while twin-pack lots span from September 2026 through July 2027. According to federal records, Sterling Pharmaceutical Services is identified as the company responsible for the recall, with distribution reaching nationwide. The FDA assigned the recall event number 99712 as part of its official enforcement documentation.
This 2026 recall follows prior federal scrutiny of Sterling’s Illinois facility, although it is a separate enforcement action. In September 2022, the FDA issued Sterling a warning letter after inspecting the plant earlier that year, citing deficiencies related to manufacturing practices involving sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall focuses on sterility assurance, following a more recent inspection. Sterling’s recall data, as provided by AvKare, indicates that no confirmed contamination or sterility failure has yet been identified.