FDA recall, , Moderate risk
Bell Pharmaceuticals Carbamide Peroxide Ear Drops
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Summary by Recall Canary from the FDA notice
What happened
Bell Pharmaceuticals, Inc., of Belle Plaine, Minnesota, recalled multiple carbamide peroxide 6.5% products distributed nationwide because they were subpotent, with a low pH and significantly reduced assay (~0.6% vs expected ~6 7%). The recall began June 25, 2026, and was added to the FDA's Enforcement Report on July 14, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
An NDC (National Drug Code) is usually printed on the drug's label.
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
- 70000-0688-1
- Lot code
- 1505333
- 2027-04
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 fl. oz. (15 mL) a) Washer Bulb included (
- NDC
- 63868-026-15
- 63868-027-16
- Lot code
- 1505121
- 1505342
- 2027-04
Product details
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL), b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158
- NDC
- 68229-102-01
- Lot code
- 1504241
- 2027-03
CAREone, Carbamide Peroxide 6.5%, 0.5 FL oz (15 mL), Bottle
- NDC
- 72476-838-34
- Lot code
- 1505141
- 2027-04
Family Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (
- NDC
- 55319-835-01
- Lot code
- 1505124
- 1505311
- 1505332
- 2027-04
Audiologist's Choice, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (
- NDC
- 59256-001-02
- 59256-836-34
- Lot code
- 1505123
- 2027-04
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (
- NDC
- 51316-822-00
- 51316-823-00
- Lot code
- 1505121
- 1504242
- 2027-03
Topcare Health, Carbamide Peroxide 6.5%, 0.5 FL oz (15 ml) a) Kit - Washer BULB & Drops Included (
- NDC
- 36800-835-33
- 36800-835-34
- Lot code
- 1505122
- 1505343
- 2027-04
Good Neighbor Pharmacy, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (
- NDC
- 46122-556-05
- 46122-557-05
- Lot code
- 1505334
- 2027-04
meijer, Carbamide Peroxide 6.5%, 0.5 FL oz (15 mL), Washer Bulb included
- NDC
- 41250-835-33
- Lot code
- 1505344
- 2027-04
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL oz (15 mL)
- NDC
- 70677-1154-01
- Lot code
- 1505161
- 1505181
- 1505301
- 1505382
- 2027-04
Recall details
- Company began the recall
- Sold in
U.S Nationwide
- Company
- Bell Pharmaceuticals, IncBelle Plaine, Minnesota
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99278
- Recall numbers
- D-0678-2026 to D-0688-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
