CLASS II Drug recall · Reported 13 Jun 2018 · FDA Enforcement Report

Fluticasone propionate Nasal Spray, USP, 50 mcg recalled by Apotex

Apotex is recalling Fluticasone propionate Nasal Spray, USP, 50 mcg, distributed nationwide in the US. The recall was initiated on 31 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: NJ4501 Exp. 07/2020

Quantity recalledUnknown

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-0841-2018
FDA event ID: 80202
Recalling firm: Apotex, North York, N/A
Classification: Class II
Status: Terminated
Recall initiated: 31 May 2018
FDA classified: 6 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Particulate Matter
Drug class: Nasal Sprays

Timeline

31 May 2018	Recall initiated by company
6 Jun 2018	Classified by FDA	+6 days
13 Jun 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of foreign substance: glass particles

Product as listed by the FDA

Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Presence of foreign substance: glass particles

Which lots are affected?

Lot: NJ4501 Exp. 07/2020

Where was it sold?

Nationwide

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 6 Oct 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
6 Mar 2024Drug	CLASS II	Fluticasone Propionate Nasal Spray USP, 50 mcg per spray recalledFluticasone Propionate	Golden State Medical Supply	Sterility	Nationwide
28 Feb 2024Drug	CLASS II	Fluticasone Propionate Nasal Spray USP 50mcg recalled by Apotex	Apotex	Sterility	Nationwide
3 Jan 2024Drug	CLASS II	Fluticasone Propionate Nasal Spray recalled by Cardinal Healthcare	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
3 Jan 2024Drug	CLASS II	Inhub Wixela (fluticasone propionate recalled by Cardinal HealthcareWixela Inhub	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
7 Jun 2023Drug	CLASS II	Fluticasone Propionate Nasal Spray, 50mcg recalled by Akorn	Akorn	Potency & Assay	Nationwide