Nearly 750,000 Eye Drop Units Recalled Over Sterility Fears

Sterling Pharmaceutical's Class II recall of 747,844 eye drop and ointment units is led by over 500,000 Walgreens products, the FDA says.

Sterling Pharmaceutical Services LLC, a contract manufacturer based in Dupo, Illinois, voluntarily initiated the recall on Aug. 20, 2026, after a lack of assurance of sterility, according to an FDA enforcement report. The action covers nine over-the-counter eye care products totaling 747,844 units distributed nationwide, including lubricant eye drops, lubricating tears, a sodium chloride ophthalmic solution and a nighttime ointment. Walgreens-branded items account for the largest share, with roughly 301,114 bottles and 199,600 twin packs of Walgreens Lubricant Eye Drops. Products sold under the AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products and Major brands are also included.

The FDA classified the recall as Class II on Sept. 21, meaning 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. Even so, the agency stresses that ophthalmic products carry heightened risk because drops applied directly to the eyes bypass some of the body's natural defenses, so eye drops must be sterile to reduce the risk of infection. That is why sterility shortfalls at a single plant can trigger recalls of this scale even without confirmed injuries.

The FDA's enforcement report lists the affected products in bottles, packs and tubes, and NTD reports the Sept. 29 update added lots and clarified descriptions for all nine items. Per NTD, recalled lots span the 3161 through 3336 range, with AvKare lots 3161 through 3306 carrying expiration dates from August 2026 through July 2027; Reliable-1's recalled lots include 3192, 3293 and 3336 for the hypertonicity solution and 3171, 3174, 3275 and 3304 for Lubricating Tears. Consumers should compare the product name, lot number and expiration date on their package against the FDA's listing at accessdata.fda.gov.

Hoodline reports that Sterling's sterility problems were not confined to human eye care — the company concurrently recalled 57,848 packs of Puralube Vet Ointment, a pet petroleum eye lubricant, from the same facility. Hoodline also reports the FDA issued Sterling a Warning Letter in September 2022 after a February 2022 inspection found inadequate environmental air monitoring in sterile processing rooms and unvalidated aseptic procedures.

The caution around unsterile eye drops traces to a severe precedent: Hoodline reports that a 2023 outbreak of drug-resistant Pseudomonas aeruginosa linked to EzriCare Artificial Tears caused four deaths, 14 cases of vision loss and more than 80 infections nationwide, marking the first U.S. report of the rare VIM-GES-CRPA bacterial strain. Unsterile drops can introduce pathogens that trigger inflammation or, in rare cases, permanent vision impairment, because liquids applied directly to the eye bypass the body's natural defense barriers. That history explains why regulators classify even remote-risk sterility failures as enforceable recalls.

No injuries tied to this recall have been confirmed so far, and the recall remained ongoing as of the FDA's latest enforcement report, with no termination date announced. Consumers who find a matching lot number and expiration date should stop using the product immediately, per FDA guidance relayed by the Daytona Beach News-Journal. Anyone who used a recalled product and experiences pain, redness, discharge or changes in vision should seek immediate clinical evaluation and tell their provider which recalled product they used. A Walgreens representative did not immediately respond to Fox Business' request for comment.