Class IIReported 2025-12-10

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.

Recalled by Blossom Pharmaceuticals

Reason for Recall

cGMP deviations

Recall Number

D-0206-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-10-31

Reported

2025-12-10

Distribution

USA Nationwide

Code Info

Lot #: A352318

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.