Recall
FDAHealthOctober 31, 2025

Blossom Pharmaceuticals — Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacram

⚠️ cGMP deviations

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 31, 2025

USA Nationwide

What's affected?

Product
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.
Lot code
A352318

Additional details

Lot #: A352318

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 912 containers.

View original FDA notice →

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