Key Takeaway:
- More than 500,000 Walgreens-branded eye-drop products are affected by the Walgreens eye drops recall over sterility concerns.
- The FDA classified the recall as Class II, indicating potential temporary or medically reversible health risks.
- The recall affects multiple brands, including AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP, and Major.
More than 500,000 Walgreens-branded eye-drop products are recalled after Sterling Pharmaceutical Services cited sterility concerns, with the FDA classifying the action Sept. 21.
FDA Classifies Recall As Class II
Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated the recall Aug. 20 because of a “lack of assurance of sterility,” according to the U.S. Food and Drug Administration’s enforcement report. The recall covers 747,844 units across nine eye-care products and remains ongoing.
The FDA classified the recall as Class II on Sept. 21. The agency defines Class II recalls as those in which exposure “may cause temporary or medically reversible adverse health consequences” or where the probability of serious harm is remote.
The Walgreens eye drops recall portion includes about 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. The affected products are distributed nationwide, according to information tied to the FDA recall.
Multiple Brands And Products Affected
The broader recall involves products sold under Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products, and Major brands.
AvKare products account for more than 120,000 twin packs of carboxymethylcellulose sodium 0.5% lubricant eye drops. Reliable-1 products include 47,616 bottles of Lubricating Tears and 11,083 bottles of 5% sodium chloride hypertonic ophthalmic solution.
The recall also covers 19,284 Cameron Pharmaceuticals lubricant eye drops, 14,538 TRP Gentle Eyes Lubricant Eye Drops, and 34,368 tubes of Major LubriFresh P.M. Nighttime Ointment. The products are intended for various eye-care uses, including relief of dryness and irritation.
The FDA says consumers should check the product name, lot number, and expiration date against the recall information before determining whether a product is affected.
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FDA Warns Of Infection Risk
The FDA says the Walgreens eye drops recall highlights why ophthalmic products require particular attention to sterility because medicines applied directly to the eyes bypass some of the body’s natural defenses.
“Any drug used in the eyes must be sterile to reduce the risk of infection,” the agency says on its consumer guidance page.
The recall follows renewed FDA scrutiny of Sterling’s manufacturing operations. The agency previously cited the company in a 2022 warning letter for problems involving aseptic processing and environmental monitoring at its Dupo facility.
Walgreens had not immediately responded to a request for comment, according to reports published about the recall. No specific consumer health outcomes were cited in the material reviewed for this report.
Consumers who believe they have a recalled product should avoid using it and consult the FDA’s recall information or a health care professional for guidance.
