Recall: D-0678-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-25Initiated

OngoingStatus

Bell Pharmaceuticals, IncFirm

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,

Reason

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

Distribution

U.S Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.