Owen Biosciences Inc.

FDA Regulatory Profile

Owen Biosciences Inc. appears in FDA public data with 4 recalls, 0 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0455-2026, Class II) was initiated on March 3, 2026.

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0455-2026Class IISLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. -March 3, 2026
D-0452-2026Class IIFHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0March 3, 2026
D-0454-2026Class IISLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, DistriMarch 3, 2026
D-0453-2026Class IIHydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottMarch 3, 2026