Recall
FDAHealthJune 25, 2026

Bell Pharmaceuticals, Inc — 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.,

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 25, 2026

U.S Nationwide

What's affected?

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,
UPC
0050428078273
Lot code
a)

Additional details

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.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 106,301 units.

View original FDA notice →

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