Class II
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,
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Recall number
- D-0678-2026
- Report date
- July 22, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Bell Pharmaceuticals, Inc
- Generic names
- CARBAMIDE PEROXIDE
- Brand names
- CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID, CVS HEALTH EARWAX REMOVAL KIT
- Product NDCs
- 51316-822, 51316-823
Code and lot information
Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.
Distribution
U.S Nationwide
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on July 28, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.