DUPO, ILLINOIS / RankWire.AI / – Nearly 748,000 eye-care products have been pulled from the market nationwide by Sterling Pharmaceutical Services due to sterility assurance issues. Among these, over 500,000 packages branded under Walgreens are included. The recall was initiated on Aug. 20 following observations during a federal inspection, leading the U.S. Food and Drug Administration to classify it as a Class II recall. This category indicates products that may cause temporary or reversible health effects, with serious health consequences being unlikely.
Walgreens items comprise 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%, which alleviates burning and irritation associated with dry eyes. The affected products were distributed across the U.S. by Walgreen Co., with several lots identified that have expiration dates extending into 2027.
The scope of the recall also extends to products marketed under various other brands and distributors. AvKare’s listings account 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 associated with Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records show a total of 747,844 affected units 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 findings from a recent inspection. These findings involved manufacturing controls and aseptic processing, both crucial for safeguarding sterile drug products from contamination. AvKare clarified that Sterling had not discovered confirmed sterility failures or evidence of contamination. The company described the recall as a precautionary measure, noting that the inspection findings affected sterility assurance. Customers were advised by AvKare to cease using the affected products.
Sterility is particularly vital for ophthalmic medicines because they are applied directly to the eyes. The FDA cited lack of sterility assurance as the reason behind this recall. Federal records specify individual lot numbers and expiration dates for each product affected. The recall encompasses products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals, all traced back to Sterling’s manufacturing facility in Dupo, Illinois.
Most of the recalled packages are Walgreens-branded
The majority of the packages involved in the recall are Walgreens lubricant eye drops, accounting for approximately two-thirds of the total. Affected single-bottle lots have expiration dates from September 2026 through June 2027, while twin-pack lots span from September 2026 to July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the responsible company and show the products were distributed 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 manufacturing plant, though it remains a separate regulatory matter. In September 2022, the FDA issued Sterling a warning letter after inspecting the facility earlier that year. The letter highlighted manufacturing practice deficiencies concerning sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall is related to sterility assurance concerns following a more recent inspection. According to AvKare, Sterling’s recall details indicate no confirmed contamination or sterility failures have been identified.