DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has issued a recall of nearly 748,000 eye-care items across the United States due to concerns regarding sterility assurance. The recall specifically involves more than 500,000 packages of Walgreens-branded lubricant eye drops. The company announced the action on August 20 after issues were identified during a federal inspection. The FDA subsequently classified it as a Class II recall. This classification pertains to products that may cause temporary or reversible health effects, while the risk of serious outcomes remains low.
Walgreens products constitute the majority of the recalled items, with federal records listing 500,714 packages. Among these are 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5%, which helps alleviate burning and irritation associated with dry eyes. The affected items were distributed nationwide by Walgreen Co., with records indicating several lots with expiration dates extending into 2027.
The scope of the recall extends to items marketed under multiple other brands and distributors. AvKare’s listings include 120,241 twin packs of lubricant eye drops. Products from Reliable-1 Laboratories include 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Additional affected products bear the names Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records show a total of 747,844 units impacted across nine product listings linked to Sterling Pharmaceutical Services.
Federal inspection raised concerns about sterility
AvKare reported that Sterling initiated the recall at the FDA‘s request following observations made during a recent inspection. These findings involved manufacturing controls and aseptic processing, critical procedures used to prevent contamination of sterile drug products. AvKare clarified that Sterling had not identified confirmed failures in sterility or evidence of product contamination. The company described the recall as a precautionary measure, noting that the inspection results affected sterility assurance. Customers were advised by AvKare to cease using the affected products.
Sterility management is particularly vital for ophthalmic medicines since they are applied directly to the eyes. The FDA attributes the recall to the lack of sterility assurance. Federal records specify individual lot numbers and expiration dates for each impacted item. The recall encompasses products from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals, all traced back to Sterling’s manufacturing site in Dupo, Illinois.
Majority of recalled packages are Walgreens-branded
Approximately two-thirds of all packages subject to the recall are Walgreens lubricant eye drops. 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 company behind the recall, indicating distribution across the country. The FDA assigned the event number 99712 as part of its official enforcement documentation.
This 2026 recall comes after prior federal scrutiny of Sterling’s Illinois facility, although it remains a separate enforcement action. In September 2022, the FDA issued Sterling a warning letter following an inspection earlier that year. The letter cited deficiencies related to sterile ophthalmic product manufacturing, contamination investigations, and aseptic processing controls. The current recall focuses on sterility assurance after a recent inspection, with Sterling’s recall details, as provided by AvKare, stating that no confirmed contamination or sterility failures have been detected.