CLASS II Drug recall · Reported 6 Jul 2022 · FDA Enforcement Report
Fluticasone Propionate Nasal Spray recalled by Akorn
Akorn is recalling Fluticasone Propionate Nasal Spray, USP, 50 mcg net fill weight per amber, distributed nationwide in the US. The recall was initiated on 13 Jun 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-1172-2022
- FDA event ID
- 90405
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jun 2022
- FDA classified
- 30 Jun 2022
- Reported
- 6 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Nasal Sprays
Timeline
| 13 Jun 2022 | Recall initiated by company | |
| 30 Jun 2022 | Classified by FDA | +17 days |
| 6 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: defect prevents product from dispensing as intended.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Defective container: defect prevents product from dispensing as intended.
Which lots are affected?
Lot #: 379073, 379079, Exp 9/30/2023
Where was it sold?
Nationwide USA
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.
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Other Fluticasone Propionate recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluticasone Propionate Nasal Spray USP, 50 mcg per spray recalledFluticasone Propionate | Golden State Medical Supply | Sterility | Nationwide |
| Drug | CLASS II | Fluticasone Propionate Nasal Spray USP 50mcg recalled by Apotex | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Fluticasone Propionate Nasal Spray recalled by Cardinal Healthcare | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Inhub Wixela (fluticasone propionate recalled by Cardinal HealthcareWixela Inhub | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Fluticasone Propionate Nasal Spray, 50mcg recalled by Akorn | Akorn | Potency & Assay | Nationwide |