FDA Drug Recalls

Recalls / Generics / Azelastine Hydrochloride

Azelastine Hydrochloride

3 FDA drug recalls involving generic “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.
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.