Nivagen — Class II drug recall D-0209-2026
Ongoing recall by Blossom Pharmaceuticals, reported 2025-12-10, distributed nationwide. cGMP deviations
| Recall number | D-0209-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blossom Pharmaceuticals, Bardej, Goa, India |
| Recall initiated | 2025-10-31 |
| Classified | 2025-12-02 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 7,920 bottles |
| Reason classes | cgmp |
| NDC | 75834-0170, 75834-0170-01, 75834-0170-02, 75834-0170-15 |
| Lot numbers | A352505 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0209-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.