Recalls / Active ingredient / Tetrahydrozoline Hydrochloride

Tetrahydrozoline Hydrochloride

10 FDA drug recalls involving the active ingredient “Tetrahydrozoline Hydrochloride” — 2 Class I.

Date	Class	Product	Firm
2026-03-03	Class II	Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL)	K.C. Pharmaceuticals, Inc
2026-03-03	Class II	EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 F	K.C. Pharmaceuticals, Inc
2026-03-03	Class II	Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Ch	K.C. Pharmaceuticals, Inc
2026-03-03	Class II	Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Steri	K.C. Pharmaceuticals, Inc
2023-11-13	Class I	Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged i	Kilitch Healthcare India Limited
2023-10-31	Class I	LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05	Cardinal Health Inc.
2023-06-13	Class II	Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ	K.C. Pharmaceuticals, Inc
2023-06-13	Class II	Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Origi	K.C. Pharmaceuticals, Inc
2014-12-04	Class III	Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05	K C Pharmaceuticals Inc
2014-12-04	Class III	Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice,	K C Pharmaceuticals Inc