DUPO, ILLINOIS / RankWire.AI / – Ensuring the sterility of eye-care products is a critical aspect of pharmaceutical manufacturing, especially for medicines applied directly to the eyes. Recently, a significant recall has been initiated due to sterility assurance issues, impacting numerous products across several brands. Sterling Pharmaceutical Services, which supplies these products, has pulled back nearly 748,000 units nationwide, including a large portion of Walgreens-branded eye drops. The recall was launched on Aug. 20, as documented in federal records. The U.S. Food and Drug Administration classified this as a Class II recall on Sept. 21, indicating a risk of temporary or medically reversible health effects, with serious harm considered unlikely.
Walgreens products make up 500,714 packages within the recall. This total includes 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. These products contain carboxymethylcellulose sodium 0.5%, offering brief relief from symptoms such as burning, irritation, and discomfort caused by dry eyes. Distribution of the affected items was handled by Walgreen Co. across the country. Federal documentation specifies NDC 0363-8833-15 and lists multiple lots with expiration dates extending into 2027.
The broader Sterling Pharmaceutical Services recall encompasses nine different product listings from various brands. Among these, AvKare lubricant eye drops account for 120,241 twin packs across two separate listings. Reliable-1 Laboratories’ affected stock includes 47,616 units of Lubricating Tears and 11,083 units of Sodium Chloride Hypertonicity Ophthalmic Solution 5%. The recall also involves Cameron Pharmaceuticals lubricant drops, TRP Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment. Collectively, these human eye-care products total 747,844 units.
Recall mandated by FDA inspection findings
AvKare stated that Sterling initiated the recall at the request of the FDA following observations made during a recent federal inspection. The concerns focused on manufacturing processes and aseptic control measures, as explained in an Aug. 25 customer recall notice. According to the notice, Sterling had not identified confirmed sterility failures or evidence of product contamination at the time. The recall was described as precautionary, since the inspection findings raised questions about sterility assurance. Customers were advised to cease further use of the affected products.
FDA regulations emphasize sterility as an essential requirement for medicines intended for direct application to the eyes. Since ophthalmic products can bypass some of the body’s natural defenses, sterile manufacturing and handling are of utmost importance. The agency’s enforcement records highlight the lack of sterility assurance as the reason behind Sterling’s recall. Specific lot numbers and expiration dates are listed for each affected product. The recall includes items from Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major Pharmaceuticals.
Walgreens items constitute the majority of recalled units
The Walgreens-branded eye drops represent approximately two-thirds of the total 747,844 units recalled. The affected single bottles feature lots with expiration dates from September 2026 through June 2027, while twin-pack lots have expiration dates spanning from September 2026 to July 2027. The FDA enforcement records specify Sterling Pharmaceutical Services of Dupo, Illinois, as the responsible company for the recall. The affected products were distributed throughout the United States, with the recall event numbered 99712.
This 2026 recall follows previous FDA scrutiny of Sterling’s Dupo operations, although it is a separate enforcement action. In September 2022, the FDA issued Sterling a warning letter after an inspection earlier that year, citing deficiencies in manufacturing practices related to sterile ophthalmic products, contamination investigations, and aseptic processing controls. The current recall, concerning Walgreens eye drops, is a sterility assurance measure prompted by a more recent FDA inspection. The AvKare notice from 2026 confirms that Sterling found no confirmed sterility failures or evidence of contamination in its products.