Fluticasone Propionate Nasal Spray USP 50mcg recall
FDA recall D-0326-2024 · initiated Feb 9, 2024
Apotex Corp. recalled Fluticasone Propionate Nasal Spray USP 50mcg in Feb 2024 — an FDA Class II recall (D-0326-2024) because CGMP Deviations: potential presence of Burkholderia cepacia complex.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: potential presence of Burkholderia cepacia complex
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 292,752 bottles
Details
- Product
- Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
- Recalling company
- Apotex
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 9, 2024
- FDA report date
- Feb 28, 2024
Frequently asked
- Was Fluticasone Propionate Nasal Spray USP 50mcg recalled?
- Apotex Corp. recalled Fluticasone Propionate Nasal Spray USP 50mcg in Feb 2024 — an FDA Class II recall (D-0326-2024) because CGMP Deviations: potential presence of Burkholderia cepacia complex. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fluticasone Propionate Nasal Spray USP 50mcg recalled?
- Per the FDA enforcement record, the reason for recall D-0326-2024 was: CGMP Deviations: potential presence of Burkholderia cepacia complex
- Is a recalled Fluticasone Propionate Nasal Spray USP 50mcg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fluticasone Propionate Nasal Spray USP 50mcg are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot number # TX5274 Exp. 09/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0326-2024.