CLASS II Drug recall · Reported 26 Oct 2022 · FDA Enforcement Report
Flunisolide Nasal Solution recalled by Ingenus Pharmaceuticals
Ingenus Pharmaceuticals is recalling Flunisolide Nasal Solution, USP 0.025%, distributed nationwide in the US. The recall was initiated on 30 Sep 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0010-2023
- FDA event ID
- 90934
- Recalling firm
- Ingenus Pharmaceuticals, Orlando, FL
- Brand
- Flunisolide
- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 30 Sep 2022
- FDA classified
- 17 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 30 Sep 2022 | Recall initiated by company | |
| 17 Oct 2022 | Classified by FDA | +17 days |
| 26 Oct 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of specification for related substances (impurities).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Out of specification for related substances (impurities).
Which lots are affected?
Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ingenus Pharmaceuticals
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Foam recalled by Ingenus Pharmaceuticals | Ingenus Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Leucovorin Calcium Injection, USP 500 mg*/ (10 mg/mL) Single-Dose recalled | Ingenus Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS III | Diclofenac Sodium Topical Solution, 1.5% w/w recalled | Ingenus Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 40 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |