Class II · Moderate risk
CAREone
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Leader (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
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
Affected NDCs
70000-0688-01
70000-0689-01
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 codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Leader Earwax Removal Drops Earwax Removal Aid Carbamide Peroxide NDC 70000-0688 |
65 mg/mL | Solution/ Drops Topical |
Cardinal Health, Inc. | OTC |
| Leader Earwax Removal Kit Earwax Removal Aid and Bulb Carbamide Peroxide NDC 70000-0689 |
Kit | Cardinal Health 110 DBA Leader | OTC |
- Recalling firm
- Bell Pharmaceuticals, Inc
- NDC code
- 70000-0689-1
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0685-2026 · 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%).
Class II · Moderate risk
Foster & Thrive
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Good Neighbor Pharmacy
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
FAMILY Wellness
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Other recalls by Bell Pharmaceuticals, Inc
All 2026 recalls
Class II · Moderate risk
CAREone
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
meijer
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Foster & Thrive
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Good Neighbor Pharmacy
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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