PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: December 10, 2025 Initiated: October 31, 2025 #D-0209-2026

Product Description

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

Details

Recalling Firm
Blossom Pharmaceuticals
Units Affected
7920 bottles
Distribution
USA Nationwide
Location
Bardej, Goa

Frequently Asked Questions

What product was recalled?
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.. Recalled by Blossom Pharmaceuticals. Units affected: 7920 bottles.
Why was this product recalled?
cGMP deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on December 10, 2025. Severity: Moderate. Recall number: D-0209-2026.