Nivagen Pharmaceuticals, Zinc Oxide Ointment Usp, Zinc Oxide 20% Skin Protectant, Net Wt. 15 Oz (425g), Made In India, Manufactured For: Nivagen Pharmaceuticals, Inc., Sacramento, Ca 95827, Usa, Ndc 7
Recall Summary Nivagen Pharmaceuticals Zinc Oxide Ointment USP 20% (15 oz containers) is being recalled nationwide due to manufacturing quality control violations. The product was made in India and distributed across all U.S. states. This is a Class I recall, the most serious classification.
- Recalling firm
- Blossom Pharmaceuticals
- Product
- Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
- 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/4b300699-035c-4ca5-82e1-323499409512