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Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (...

FDA Recall #D-0206-2026 — Class II — October 31, 2025

Recall #D-0206-2026 Date: October 31, 2025 Classification: Class II Status: Ongoing

Product Description

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.

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

912 containers

Distribution

USA Nationwide

Code Information

Lot #: A352318

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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