FDA recall D-0208-2026
Blossom Pharmaceuticals · Class II · drug
Product
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
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-0208-2026