Class IIOngoing

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmace… recall

FDA recall D-0209-2026 · initiated Oct 31, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

cGMP deviations

Details

Product: 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.
Recalling company: Blossom Pharmaceuticals
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: Oct 31, 2025
FDA report date: Dec 10, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0209-2026 ↗

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