Ingenus Flunisolide Nasal Solution 0.025% Recall: Impurities Risk
Ingenus Pharmaceuticals recalls Flunisolide Nasal Solution 0.025% 25mL bottles due to impurities. Rx-only product with specific lot numbers and expiration dates. Consumers should contact for details.
Recall notice
Out of specification for related substances (impurities).
Contact the company
What happened, in plain English
Ingenus Pharmaceuticals is recalling Flunisolide Nasal Solution 0.025% 25mL bottles because they contain impurities that may be unsafe. This is a prescription-only product that could pose health risks if used improperly. Read more at govinfonow.com/recall/34310-ingenus-flunisolide-nasal-solution-0-025-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34310-ingenus-flunisolide-nasal-solution-0-025-recall-impurities-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0010-2023
Cite this page
“Ingenus Flunisolide Nasal Solution 0.025% Recall: Impurities Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34310-ingenus-flunisolide-nasal-solution-0-025-recall-impurities-risk. Based on FDA recall #D-0010-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0010-2023%22&limit=1).
Why it’s dangerous
The product contains impurities that may not meet safety standards. These impurities could potentially cause health issues when used as directed. The exact health risk is not specified in the recall notice.
Who’s affected
Prescription users of Flunisolide Nasal Solution 0.025% 25mL bottles manufactured by Ingenus Pharmaceuticals. Those with specific lot numbers (22E040 or 22F038) and expiration dates (July 2023 or August 2023) are most at risk.
How to tell if you have this one
Check the product label for the lot number (22E040 or 22F038) and expiration date (July 2023 or August 2023). The product is a prescription-only nasal spray with NDC 50742-317-25.
- Brand
Ingenus Pharmaceuticals- Product
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number (22E040 or 22F038) and expiration date (July 2023 or August 2023) on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0010-2023 (September 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0010-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.