Nivagen recalled over manufacturing violations

Recall date

October 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Blossom Pharmaceuticals recalls Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA…

Recall number

D-0209-2026

FDA classification

Class II

Brand / firm

Blossom Pharmaceuticals

Sold / distributed

USA Nationwide

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.