Carbamide Peroxide recalls: 11 FDA reports
Recalls involving Carbamide Peroxide. What was wrong with each batch, and how the FDA graded the risk.
11Reports
0Class I
10Ongoing
2026-07-22Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b
D-0680-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.
- Where it went
- U.S Nationwide
- How much
- 15, 843 units
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL
D-0679-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- 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.
- Where it went
- U.S Nationwide
- How much
- 29, 474 units
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000
D-0685-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- 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 went
- U.S Nationwide
- How much
- 5, 471 units
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), D
D-0683-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.
- Where it went
- U.S Nationwide
- How much
- 11, 977 units
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A,
D-0688-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- 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.
- Where it went
- U.S Nationwide
- How much
- 1,201 units
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DI
D-0687-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
- Where it went
- U.S Nationwide
- How much
- 993 units
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syring
D-0678-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
- Where it went
- U.S Nationwide
- How much
- 106,301 units
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-83
D-0681-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
- Where it went
- U.S Nationwide
- How much
- 16,156 units
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-
D-0682-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
- Where it went
- U.S Nationwide
- How much
- 5,762 units
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-
D-0684-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Product
- GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
- Where it went
- U.S Nationwide
- How much
- 20, 160 units
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC
D-1318-2022 · Class II · reported 2022-08-17 · Terminated
- Why it was recalled
- CGMP Deviations: products were stored outside the drug label specifications.
- Product
- Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
- Where it went
- Nationwide in the USA.
- How much
- 131 boxes
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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