FDA Drug Recalls

Recalls / Active ingredient / Azelastine Hydrochloride

Azelastine Hydrochloride

5 FDA drug recalls involving the active ingredient “Azelastine Hydrochloride”.

DateClassProductFirm
2025-05-28Class IIAzelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, OntarioApotex Corp.
2019-02-01Class IIDymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 MeterMylan Pharmaceuticals Inc.
2018-07-25Class IIDymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packageMylan Pharmaceuticals Inc.
2018-02-05Class IIIAzelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun PharSun Pharmaceutical Industries, Inc.
2011-06-15Class IIIAzelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: ApoteApotex Corp.