FDA recall D-0206-2026

Blossom Pharmaceuticals · Class II · drug

Product

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

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-10-31
Report date: 2025-12-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bardej, Goa, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0206-2026