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.

Recall Number: D-0683-2026

Firm: Bell Pharmaceuticals, Inc

Classification: Class II

Status: Ongoing

Report Date: 20260722

Initiation Date: 20260625

Termination Date:

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

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.