Nivagen, Zinc Oxide Ointment, Net Wt. 1 Oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, Ca 95827, USA Made In India, Ndc 75834-170-01.
Recall Summary Nivagen Zinc Oxide Ointment (1 oz) is being recalled nationwide due to manufacturing process deviations that failed to meet required safety standards. The product was distributed across all U.S. states and was manufactured in India by Nivagen Pharmaceuticals. This is classified as a Class I recall, the most serious category.
- Recalling firm
- Blossom Pharmaceuticals
- 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
- 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/b2c095d0-ceb8-487b-bb82-3c5905290069