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FDAFDA · Food and drugs·Recall number D-0206-2026

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.

Published December 10, 2025 · Recall initiated: October 31, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

cGMP deviations

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
NIVAGEN ZINC OXIDE
Manufacturer
Blossom Pharmaceuticals
Distributor
USA Nationwide
Lot
Lot #: A352318
Risk classification
Class II
Area (FDA)
drug
Country
India

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