DUPO, ILLINOIS — Sterling Pharmaceutical Services LLC initiated a recall of eye-care products on Aug. 20 due to a lack of assurance of sterility. The recall involves nearly 750,000 eye-care products across multiple brands.

The recall includes eye-care products distributed under the AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products, and Major brands. More than 120,000 packages of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops are affected. The AvKare portion of the recall includes more than 12,800 packs of Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops (0.5 fluid ounces) and 107,377 packs of two-count twin packs.

The TRP The Relief Products portion of the recall includes 14,538 bottles of Gentle Eyes Lubricant Eye Drops. The recall includes Major LubriFresh P.M. Nighttime Ointment. The Major portion of the recall includes 34,368 tubes of LubriFresh P.M. Nighttime Ointment (0.125 ounces).

The FDA classified the recall as Class II on Sept. 21. A Class II recall designation means use of or exposure to the affected products may cause temporary or medically reversible health consequences, while the probability of serious health consequences is considered remote. The FDA states that ophthalmic products pose a heightened risk because drugs applied to the eyes bypass some of the body’s natural defenses.

The FDA states that eye drops must be sterile to reduce the risk of infection. The FDA advises consumers with affected products to immediately stop using them and speak with their doctors.

Timeline

In July 2026, 2.5 million bottles of Lupin Pharmaceuticals prescription eye drops were recalled due to contamination concerns. In August 2026, more than 39,000 bottles of Clear Eyes Maximum Itchy Eye Relief were recalled.

The FDA's enforcement record for this recall lists multiple affected lot numbers and expiration dates for the products, with the agency updating the recall information on September 29, 2026, including additional lot information and product-description details.

What's New

Additional reporting indicates that Walgreens Lubricant Eye Drops account for 301,114 bottles and 199,600 twin-pack units in the recall, totaling 500,714 units, making them the largest single product category in the recall. Sterling Pharmaceutical Services LLC has previously faced recalls related to sterility concerns, including the 2026 recall of 3.1 million bottles of store-brand eye drops from KC Pharmaceuticals, which was also linked to sterility issues.

Sterling Pharmaceutical Services LLC also recalled 57,848 packs of Puralube Vet Ointment, a non-prescription pet petroleum eye lubricant, on August 20 due to sterility issues at the same facility that affected human eye-care products. In August 2022, the FDA issued a Warning Letter to Sterling Pharmaceutical Services LLC after an inspection uncovered major manufacturing violations, including inadequate environmental air monitoring in sterile processing rooms and unvalidated aseptic procedures.

The Cameron Pharmaceuticals portion of the recall includes 19,284 bottles of Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops (0.5 fluid ounces).

Why It Matters

The recall affects nearly 750,000 units of eye-care products, with Walgreens-branded items constituting the majority at more than 500,000 units. The FDA classifies this as a Class II recall, indicating that while serious health consequences are remote, temporary or medically reversible issues are possible. The agency emphasizes that ophthalmic products carry heightened risk because they bypass natural bodily defenses, making sterility critical to preventing infection.

This event fits a pattern of sterility-related recalls involving Sterling Pharmaceutical Services LLC, which previously recalled 3.1 million bottles of KC Pharmaceuticals store-brand eye drops in 2026 for similar issues. The company also recalled pet eye lubricant from the same facility in August 2026. Regulatory history shows the FDA issued a Warning Letter to the manufacturer in August 2022 after finding inadequate environmental air monitoring and unvalidated aseptic procedures during an inspection.