DUPO, ILLINOIS / RankWire.AI / – Sterling Pharmaceutical Services has initiated a recall of nearly 748,000 eye-care products across the country due to concerns regarding sterility assurance. Among these are more than 500,000 packages of Walgreens-branded lubricant eye drops. The recall process began on Aug. 20 after issues were identified during a federal inspection. The U.S. Food and Drug Administration classified this action as a Class II recall, indicating the products could cause temporary or medically reversible health effects, though serious health consequences are considered 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 is intended to ease burning and irritation associated with dry eyes. Distribution of the affected items was carried out nationwide by Walgreen Co., with certain lots having expiration dates that extend into 2027, according to records.
In addition to Walgreens, products from several other brands and distributors are part of the recall. AvKare’s listings include 120,241 twin packs of lubricant eye drops, while Reliable-1 Laboratories supplies 47,616 units of Lubricating Tears and 11,083 units of sodium chloride ophthalmic solution. Other brands affected include Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. Federal records show a total of 747,844 units across nine product listings tied to Sterling Pharmaceutical Services are impacted by this recall.
Federal inspection raised concerns about sterility
AvKare stated 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, procedures essential for safeguarding sterile drug products from contamination. AvKare emphasized that Sterling had not identified confirmed sterility failures or evidence of product contamination. The recall is described as precautionary, since the inspection findings impacted the assurance of sterility. Customers have been advised by AvKare to cease use of the affected products.
Given that ophthalmic medications are applied directly to the eyes, sterility controls are especially critical in this context. The FDA cites the lack of sterility assurance as the primary reason for the current recall. Federal records specify lot numbers and expiration dates for each impacted product, which include Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals. All affected products trace back to Sterling’s manufacturing facility located in Dupo, Illinois.
Majority of recalled packages are from Walgreens
Approximately two-thirds of all packages involved in the recall are Walgreens lubricant eye drops. Lots with single bottles expire between September 2026 and June 2027, while twin-pack lots have expiration dates spanning from September 2026 to July 2027. Federal enforcement records identify Sterling Pharmaceutical Services as the responsible manufacturer and confirm distribution across the United States. The FDA has assigned the official recall event number 99712 to this action as part of its formal enforcement documentation.
This 2026 recall follows prior federal scrutiny of Sterling’s Illinois facility, although it is handled as a separate regulatory matter. In September 2022, the FDA issued a warning letter to Sterling after inspecting the plant earlier that year, citing deficiencies related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall addresses sterility assurance concerns following a more recent inspection. According to AvKare, Sterling’s recall information indicates that no confirmed contamination or sterility failure has been detected to date.
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