Why it was recalled
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Where it was sold
U.S Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0685-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 25, 2026
- FDA report date
- Jul 22, 2026
- Quantity
- 5, 471 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bell Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-0685-2026, exactly as published.
Show all FDA fields
- City
- Belle Plaine
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 99278
- Address
- 200 W Beaver St
- Code information
- Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
- Postal code
- 56011-1894
- Report date
- Jul 22, 2026
- Product type
- Drugs
- Recall number
- D-0685-2026
- Classification
- Class II
- Recalling firm
- Bell Pharmaceuticals, Inc
- Product quantity
- 5, 471 units
- Reason for recall
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S Nationwide
- Recall initiation date
- Jun 25, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2026