Nivagen Pharmaceuticals 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 Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India,…

Recall number

D-0206-2026

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 Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.