Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, C...

FDA Recall #D-0208-2026 — Class II — October 31, 2025

Recall #D-0208-2026 Date: October 31, 2025 Classification: Class II Status: Ongoing

Product Description

Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.

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

13536 containers

Distribution

USA Nationwide

Code Information

Lot #: A352405

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated