Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals...
FDA Recall #D-0209-2026 — Class II — October 31, 2025
Product Description
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.
Reason for Recall
cGMP deviations
Recalling Firm
Blossom Pharmaceuticals — Bardej, Goa
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7920 bottles
Distribution
USA Nationwide
Code Information
Lot #: A352505
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated