Flunisolide Nasal Solution — Class II drug recall D-0010-2023
Completed recall by Ingenus Pharmaceuticals Llc, reported 2022-10-26, distributed nationwide. Out of specification for related substances (impurities).
| Recall number | D-0010-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ingenus Pharmaceuticals Llc, Orlando, FL, United States |
| Recall initiated | 2022-09-30 |
| Classified | 2022-10-17 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 6,176 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00350742317257 |
| NDC | 50742-0317, 50742-0317-25 |
| Lot numbers | 22E040, 22F038 |
| Expiration dates | 2023-07, 2023-08 |
Product
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
Reason for recall
Out of specification for related substances (impurities).
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-0010-2023. 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.