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.
Recall Summary Nivagen Zinc Oxide Ointment USP 20% (1 oz tubes, NDC 75834-170-02) is being recalled nationwide due to manufacturing process deviations that do not meet required standards. The product was distributed across all U.S. states and the District of Columbia. This is classified as a Class I recall, the most serious classification.
- Recalling firm
- Blossom Pharmaceuticals
- 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
- cGMP deviations
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-10-31
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/267a4bed-73b6-41c4-8abf-cb0145d7d7ce