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Coverage: July 28, 2024–July 28, 2026. Dataset last checked Jul 28, 2026 UTC.

Latest records

Recently reported recalls

1,433 records in the current dataset

Class II

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35

Padagis US LLC

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

D-0677-2026

July 22, 2026

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,

Bell Pharmaceuticals, Inc

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

D-0678-2026

July 22, 2026

Class II

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.

Bell Pharmaceuticals, Inc

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

D-0679-2026

July 22, 2026

Class II

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.

Bell Pharmaceuticals, Inc

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

D-0680-2026

July 22, 2026

Class II

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.

Bell Pharmaceuticals, Inc

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

D-0681-2026

July 22, 2026

Class II

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.

Bell Pharmaceuticals, Inc

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

D-0682-2026

July 22, 2026

Class II

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.

Bell Pharmaceuticals, Inc

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

D-0683-2026

July 22, 2026

Class II

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.

Bell Pharmaceuticals, Inc

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

D-0684-2026

July 22, 2026