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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted July 23, 2025
FDA Warns Seller of Allegro Eye Drops, Tea Tree Oil Eyelid Wipes, and More
On July 9, 2025, the FDA issued a Warning Letter to Scope Health Inc. following a review of their product labeling and website that found statements made about several of the company’s over-the-counter (OTC) eye drop and eyelid cleansing products, including MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, HYLO Night Eye Ointment, Tea Tree Oil Eyelid Wipes, Tea Tree Oil Eyelid Gel, and Protect Eyelid Cleansing Spray, to be drug claims. Certain products also contained ingredients that are not permitted as active ingredients.
(See ConsumerLab’s CL Answer about supplements and eye drops for dry eye, which includes our comparison of OTC eye drops. Also see CL’s Review of Lavender and Tea Tree Essential Oils for information about the clinical evidence and safety of tea tree oil products.)
According to the FDA’s Warning Letter, the company’s website discussed managing diseases such as blepharitis and meibomian gland dysfunction, and product packaging and the company website promoted products with statements such as "relieve dry eye symptoms," "comfort from moderate to severe dry eye," "first line of defense to stop environmental irritants.”
The FDA also warned that some the company’s eye drops contained ingredients such as sacha inchi seed oil, trehalose, and sodium hyaluronate, that are not active ingredients permitted for ophthalmic demulcent drug products, and some products lacked required warnings on the labels, such as “If solution changes color or becomes cloudy, do not use.”
Scope Health Inc. must respond to the FDA in writing within 15 working days of receipt of the Warning Letter, detailing the specific steps taken to correct the violations and prevent their recurrence.
For more information, use the link below.
FDA Issues Warnings to Scope Health Inc. for Unapproved and Misbranded Ophthalmic Drug Products
See related recalls and warnings:
Microbial Contamination Found in LightEyez MSM Eye Drops
Dr. Berne’s Whole Health Products Warned for Contaminated Eye Drop Products, Drug Claims
Belmont Eyecare Warned for Colloidal Silver, MSM, and Castor Oil Eye Drop Claims
FDA Warns CVS, Walgreens, Similasan & Others for Eye Drop Violations
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