Drug & medication recalls Moderate risk

Nivagen recalled over manufacturing violations

Recall date
October 31, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Blossom Pharmaceuticals recalls Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in I…
Recall number
D-0208-2026
FDA classification
Class II
Brand / firm
Blossom Pharmaceuticals
Sold / distributed
USA Nationwide

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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