FDA recall D-0209-2026

Blossom Pharmaceuticals · Class II · drug

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.

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-0209-2026