Azelastine Hydrochloride recalls

Azelastine Hydrochloride products have been recalled 3 times, most recently on 2 Jul 2025. The recalling company is usually Apotex. The most common reason is sterility.

Total recalls3since 2012

Last 12 months0reported

Class I00% of total

Ongoing1latest 2 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 1Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 1 33%Class III 2 67%

Why azelastine hydrochloride is recalled

Companies

Apotex267%
Sun Pharmaceutical Industries133%

Product types

Nasal Sprays267%
Eye Drops133%

By year

2025133%
2018133%
2012133%

Ongoing azelastine hydrochloride recalls

1 active

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Drug	CLASS II	Azelastine HCl Ophthalmic Solution recalled by ApotexAzelastine Hydrochloride	Apotex	Sterility	Nationwide

All azelastine hydrochloride recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Drug	CLASS II	Azelastine HCl Ophthalmic Solution recalled by ApotexAzelastine Hydrochloride	Apotex	Sterility	Nationwide
21 Feb 2018Drug	CLASS III	Azelastine HCl Nasal Solution (Nasal Spray) 1% (137 mcg per spray) recalledAzelastine Hydrochloride	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Sep 2012Drug	CLASS III	Azelastine HCl Nasal Solution, 1 %, 137 mcg/spray bottle recalledAzelastine Hydrochloride	Apotex	Manufacturing (CGMP) Deviations	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.