Sterling Pharmaceutical Services has recalled nearly 750,000 eye drop and ointment units sold under brands including Walgreens after the FDA flagged a lack of sterility assurance.
USA TODAY reported that the recall covers nine ophthalmic products totaling 747,844 units because the company could not assure the products are sterile.
Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, started the recall on Aug. 20, 2026, according to an FDA enforcement report. The Food and Drug Administration later ranked the action as Class II on Sept. 21.
These are drops and ointments people put directly in their eyes. Sterility is not a side issue. When a manufacturer cannot stand behind it, shoppers need plain facts, lot numbers, and a clear next step.
Walgreens-labeled lubricant eye drops account for the largest share of the recalled stock. The FDA-linked tally lists 301,114 single 0.5-fluid-ounce bottles and 199,600 two-count twin packs under that brand alone.
Other labels sit in the same action. Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Eye Lubricant covers 19,284 bottles. AvKare’s matching 0.5% lubricant line includes 12,864 single packs and 107,377 twin packs.
Reliable-1 Laboratories products in the recall include 11,083 bottles of Sodium Chloride Hypertonicity Ophthalmic Solution 5% and 47,616 bottles of Lubricating Tears. TRP The Relief Products Gentle Eyes Lubricant Eye Drops add 14,538 bottles. Major LubriFresh P.M. Nighttime Ointment accounts for 34,368 tubes of 0.125 ounces each.
Taken together, the nine lines reach the 747,844-unit total published with the recall notice.
The FDA’s Class II label is specific. The agency’s standard, as carried in the coverage, is that exposure or use “may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.”
"means exposure to or use of the recalled product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote."
No injuries, infections, or adverse-event counts appear in the public write-up of this recall. The stated problem is narrower and still serious for eye products: a lack of assurance that the bottles and tubes are sterile.
Regulators tell shoppers to match lot numbers and expiration dates against the FDA Enforcement Report for the event. If a bottle or tube is covered, the guidance is blunt.
Consumers should, in the agency’s wording relayed by reporters, “immediately stop using the eye drops and speak with their doctors.”
"immediately stop using the eye drops and speak with their doctors."
USA TODAY reached out to Sterling Pharmaceutical Services on Oct. 2, 2026. As of publication that afternoon, the company had not responded.
That leaves the FDA enforcement report and classification as the main public record. The report ties the Aug. 20 start date to Sterling’s action and records the Sept. 21 Class II decision. Full lot and expiration lists sit in the agency’s enforcement materials rather than in the news summary.
Retail footprint beyond the brand names is not spelled out in the available notice. Neither are manufacturing details on how the sterility assurance gap was found. Shoppers still have the practical tools that matter most at the bathroom cabinet: brand, product name, lot code, expiration date, and the stop-use instruction.
Eye medicine is not a place for fuzzy quality control. When nearly three-quarters of a million units cannot be vouched for as sterile, the right response is the one regulators already gave, pull them, check the lot, and call the doctor if that bottle was yours.