DUPO, ILLINOIS / RankWire.AI / – Nearly 748,000 eye-care items have been pulled from shelves across the country due to sterility concerns, with a significant portion being Walgreens-branded lubricating eye drops. The recall was triggered by Sterling Pharmaceutical Services, which announced on Aug. 20 that these products were being withdrawn, as documented in federal records. The U.S. Food and Drug Administration (FDA) classified this as a Class II recall on Sept. 21, indicating products that might cause temporary or reversible health effects, with serious harm being unlikely.
Walgreens products make up 500,714 packages included in this recall. Among them are 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These items contain carboxymethylcellulose sodium 0.5% and are used to temporarily relieve dry-eye symptoms such as burning, irritation, and discomfort. Distribution of the affected products was carried out nationwide by Walgreen Co. Federal records specify NDC 0363-8833-15 and list various lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall encompasses nine different product listings from multiple brands. For example, AvKare lubricant eye drops account for 120,241 twin packs across two listings. Reliable-1 Laboratories’ affected products include 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5%. Additional products under this recall are Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. In total, these human eye-care items number 747,844 units.
Recall issued following FDA inspection observations
AvKare indicated that Sterling Pharmaceutical Services initiated the recall at the request of the FDA after issues were noted during a recent federal inspection. The concerns involved manufacturing processes and aseptic control measures, as stated in an Aug. 25 customer recall notice. Sterling had not identified confirmed sterility failures or signs of contamination in the products. The recall was described as precautionary, with the inspection findings raising potential sterility assurance concerns. Customers were advised to cease using the affected products immediately.
FDA regulations emphasize sterility as an essential aspect for medicines applied directly to the eyes. Because ophthalmic products bypass some natural defenses, maintaining sterile manufacturing and handling is crucial. The FDA’s enforcement record points to lack of sterility assurance as the reason behind this recall. Specific lot numbers and expiration dates are listed for each affected product, spanning Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens products constitute the majority of recalled units
Approximately two-thirds of the total 747,844 packages subject to the recall are Walgreens lubricant eye drops. Affected single-bottle lots have expiration dates from September 2026 to June 2027, while twin-pack lots range from September 2026 through July 2027. The FDA enforcement record attributes the recall to Sterling Pharmaceutical Services of Dupo, Illinois, citing nationwide distribution. The event is identified with recall number 99712.
This 2026 recall follows prior FDA scrutiny of Sterling’s operations in Dupo, although it is a distinct regulatory matter. In September 2022, the FDA issued Sterling a warning letter after an earlier inspection that year, citing issues related to manufacturing practices for sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall of Walgreens eye drops concerns sterility assurance following a recent FDA inspection. AvKare’s notice from 2026 confirms that Sterling found no confirmed sterility failures or contamination issues in the products.