Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Jun 25, 2026 (4 months ago)

CAREone (Carbamide Peroxide)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.

Affected NDC 72476-0838-34

Compare with the code on your package — it is the most precise check available.

Drug: Carbamide

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
CareOne Earwax Removal Drops
Carbamide Peroxide
NDC 72476-0838
65 mg/mL Solution/ Drops
Auricular (otic)
Retail Business Services, LLC OTC
Recalling firm
Bell Pharmaceuticals, Inc
NDC code
72476-838-34
Origin
MN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0688-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Carbamide recalls

See all
Class II · Moderate risk

meijer

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 41250-835-33 D-0687-2026
Class II · Moderate risk

Foster & Thrive

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 70677-1154-01 D-0686-2026
Class II · Moderate risk

Leader

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 70000-0689-1 D-0685-2026
Class II · Moderate risk

Good Neighbor Pharmacy

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 46122-556-05 D-0684-2026
Class II · Moderate risk

FAMILY Wellness

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 55319-835-01 D-0683-2026

Other recalls by Bell Pharmaceuticals, Inc

All 2026 recalls
Class II · Moderate risk

meijer

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 41250-835-33 D-0687-2026
Class II · Moderate risk

Foster & Thrive

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 70677-1154-01 D-0686-2026
Class II · Moderate risk

Leader

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 70000-0689-1 D-0685-2026
Class II · Moderate risk

Good Neighbor Pharmacy

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 46122-556-05 D-0684-2026