The FDA has recalled an estimated 244,432 containers of 6.5% carbamide peroxide ear drops after testing found the active ingredient dramatically reduced (~0.6% measured vs the expected ~6–7%), which may render the products ineffective. The nationwide recall, announced June 25 and detailed July 14, affects 11 products sold primarily in 0.5-ounce bottles across multiple retail brands and lots. The agency labeled the action a Class II recall; consumers should stop using affected bottles, check lot numbers and expiration dates, and follow FDA or retailer instructions for returns or disposal.
FDA Pulls 244,432 Ear Drop Containers After Tests Find Low Active Ingredient
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This summer federal health data and a major product recall intersect: the U.S. Food and Drug Administration has removed roughly 244,432 containers of 6.5% carbamide peroxide ear drops from the U.S. market after laboratory testing found the products to be subpotent.
What Happened?
On June 25 the FDA announced a recall of 11 peroxide ear-drop products; the agency published details on July 14. Lab results reported a significantly reduced assay (about ~0.6% measured vs the expected ~6–7%), meaning some bottles may contain roughly 10% of the labeled active ingredient. Such low potency could make the product ineffective for softening and loosening earwax.
Products, Packaging and Distribution
The recalled units were primarily 0.5-ounce bottles and other "bottle" packaging, distributed nationwide. The FDA classified the action as a Class II recall, indicating that use of or exposure to the affected products may cause temporary or medically reversible adverse health consequences and that serious adverse outcomes are unlikely.
Brands And Affected Lot Numbers
Consumers should check lot numbers and expiration dates carefully. The FDA-listed affected brands and lots include (expiration dates shown where available):
- CVS Health — Lots: 1505121, 1504242 (exp 2027-03); 1505132, 1505182, 1505191, 1505291, 1505331 (exp 2027-04); 1504231, 1504311 (exp 2027-03); 1505312, 1505321 (exp 2027-04)
- Clinere — Lots: 1504241 (exp 2027-03); 1504291, 1504301 (exp 2027-03)
- QC Quality Choice — Lots: 1505121, 1505342, 1505381 (exp 2027-04)
- TopCare Health — Lots: 1505122, 1505343, 1505142, 1505341 (exp 2027-04)
- Audiologist's Choice — Lots: 1505123, 1505131 (exp 2027-04)
- Family Wellness — Lots: 1505124, 1505311, 1505332 (exp 2027-04)
- Good Neighbor Pharmacy — Lots: 1505334, 1505143, 1505151 (exp 2027-04)
- Leader — Lots: 1505333, 1505144, 1505302 (exp 2027-04)
- Foster & Thrive — Lots: 1505161, 1505181, 1505301, 1505382 (exp 2027-04)
- Meijer — Lot: 1505344 (exp 2027-04)
- CAREone — Lot: 1505141 (exp 2027-04)
What Consumers Should Do
If you have one of the listed products, stop using it immediately. Compare the lot number and expiration date on your bottle with the FDA list above. Follow instructions from the retailer or the FDA for returns or disposal. If you experience ear pain, drainage, hearing loss, persistent irritation, or other concerning symptoms after using the product, contact your healthcare provider.
Why It Matters
The Cleveland Clinic notes that 6.5% carbamide peroxide is commonly used to soften and loosen earwax to aid removal. A subpotent product may fail to provide the expected benefit and could delay appropriate care. The recall comes as respiratory infections and related ear, nose or throat symptoms have been elevated in national surveillance this summer.
Bottom Line: Check your medicine cabinet. If you find a recalled bottle, stop using it and follow FDA or retailer guidance for returns or disposal.
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