Skip to content

Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: products were stored outside the drug label specifications.

What was recalled

Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
NDC code: 63029-321-01
Origin: VA, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-1318-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Carbamide recalls

Class II · Moderate risk Ongoing Jun 25, 2026

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…

Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc NDC 72476-838-34 D-0688-2026

Class II · Moderate risk Ongoing Jun 25, 2026

meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC…

Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc NDC 41250-835-33 D-0687-2026

Class II · Moderate risk Ongoing Jun 25, 2026

Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL…

Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc NDC 70677-1154-01 D-0686-2026

Class II · Moderate risk Ongoing Jun 25, 2026

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…

Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc NDC 70000-0689-1 D-0685-2026

Class II · Moderate risk Ongoing Jun 25, 2026

GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1…

Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc NDC 46122-556-05 D-0684-2026