FDA Recall D-0209-2026
Blossom Pharmaceuticals
Class II Ongoing 195 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
cGMP deviations
Recall record
- Recall number
D-0209-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2025-10-31
- Classified by FDA Center
- 2025-12-02
- FDA published
- 2025-12-10
- Recalling firm
- Blossom Pharmaceuticals
Drug identification
- Brand name(s)
- NIVAGEN ZINC OXIDE
- Generic name(s)
- ZINC OXIDE
- Manufacturer(s)
- Nivagen Pharmaceuticals, Inc.
- NDC(s)
75834-170- Route(s)
- TOPICAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.