Azelastine recalls

The FDA has published 8 recalls involving Azelastine since 2012. The latest was reported on 2 Jul 2025. Most were for potency & assay. Akorn has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2012

Last 12 months0reported

Class I00% of total

Ongoing2latest 2 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 1 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 4 50%Class III 4 50%

Why azelastine is recalled

Companies

Brands

Azelastine Hydrochloride338%
Dymista225%

By year

2025113%
2023113%
2019113%
2018338%
2017113%
2012113%

Ongoing azelastine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Drug	CLASS II	Azelastine HCl Ophthalmic Solution recalled by ApotexAzelastine Hydrochloride	Apotex	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray recalled	Akorn	Potency & Assay	Nationwide

All azelastine recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Drug	CLASS II	Azelastine HCl Ophthalmic Solution recalled by ApotexAzelastine Hydrochloride	Apotex	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray recalled	Akorn	Potency & Assay	Nationwide
13 Feb 2019Drug	CLASS II	Dymista (azelastine hydrochloride recalled by Mylan PharmaceuticalsDymista	Mylan Pharmaceuticals	Foreign Material	Nationwide
5 Sep 2018Drug	CLASS III	Azelastine HCl Ophthalmic Solution 0.05% in HDPE bottle recalled	Akorn	Potency & Assay	Nationwide
15 Aug 2018Drug	CLASS II	Dymista (azelastine hydrochloride recalled by Mylan PharmaceuticalsDymista	Mylan Pharmaceuticals	Foreign Material	Nationwide
21 Feb 2018Drug	CLASS III	Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray) recalledAzelastine Hydrochloride	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
1 Feb 2017Drug	CLASS III	Azelastine Hydrochloride Nasal Solution (Nasal Spray) recalled	Roxane Laboratories	Potency & Assay	Nationwide
5 Sep 2012Drug	CLASS III	Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray bottle recalledAzelastine Hydrochloride	Apotex	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Azelastine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.