CLASS II ONGOING Drug recall · Reported 22 Jul 2026 · FDA Enforcement Report
Leader, Carbamide Peroxide recalled by Bell Pharmaceuticals
Bell Pharmaceuticals is recalling Leader, Carbamide Peroxide 6.5%, a) Kit -1 Rubber Bulb Syringe Drops, (, distributed nationwide in the US. The recall was initiated on 25 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0685-2026
- FDA event ID
- 99278
- Recalling firm
- Bell Pharmaceuticals, Belle Plaine, MN
- Manufacturer
- Cardinal Health 110 DBA Leader
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2026
- FDA classified
- 14 Jul 2026
- Reported
- 22 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 25 Jun 2026 | Recall initiated by company | |
| 14 Jul 2026 | Classified by FDA | +19 days |
| 22 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
U.S Nationwide
Questions about this recall
Why was it recalled?
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Which lots are affected?
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Where was it sold?
U.S Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 99278This product is part of a recall event; the main page for the event is QC Quality Choice, Carbamide Peroxide recalled by Bell Pharmaceuticals.
More recalls from Bell Pharmaceuticals
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Foster & Thrive, Carbamide Peroxide recalled by Bell Pharmaceuticals | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Good Neighbor Pharmacy, Carbamide Peroxide 6.5%, a) Kit recalledGood Neighbor Pharmacy Earwax Removal | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Audiologist's Choice, Carbamide Peroxide 6.5% a) Kit recalledAudiologists Choice Earwax Removal System | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | TopCare Health, Carbamide Peroxide 6.5% a) Kit recalledTopcare Earwax Removal Kit | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | CVS Health, Carbamide Peroxide, 6.5%, a) Bottle recalledCvs Health Earwax Removal Drops Earwax Removal Aid | Bell Pharmaceuticals | Potency & Assay | Nationwide |
Other Carbamide Peroxide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Good Neighbor Pharmacy, Carbamide Peroxide 6.5%, a) Kit recalledGood Neighbor Pharmacy Earwax Removal | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Audiologist's Choice, Carbamide Peroxide 6.5% a) Kit recalledAudiologists Choice Earwax Removal System | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | TopCare Health, Carbamide Peroxide 6.5% a) Kit recalledTopcare Earwax Removal Kit | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | CVS Health, Carbamide Peroxide, 6.5%, a) Bottle recalledCvs Health Earwax Removal Drops Earwax Removal Aid | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | meijer, Carbamide Peroxide 6.5%, Washer Bulb included recalledMeijer Earwax Removal Kit | Bell Pharmaceuticals | Potency & Assay | Nationwide |