Tetrahydrozoline recalls

The FDA has published 7 recalls involving Tetrahydrozoline since 2014. The latest was reported on 14 Oct 2026. Most were for sterility. K.C. Pharmaceuticals 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 recalls7since 2014

Last 12 months4reported

Class I00% of total

Ongoing5latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 2 0 0Jun 0 0 0Sep 2 0

Severity split

Class I 0 0%Class II 6 86%Class III 1 14%

Why tetrahydrozoline is recalled

Sterility457%
Manufacturing (CGMP) Deviations343%

Companies

K.C. Pharmaceuticals686%
Spectrum Laboratory Products114%

Brands

By year

2026457%
2023114%
2014229%

Ongoing tetrahydrozoline recalls

5 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile Eye Drops, Original recalled by K.C. PharmaceuticalsGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%) recalledGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
19 Jul 2023Drug	CLASS II	Original Eye Drops recalled by K.C. PharmaceuticalsSunmark Eye Drops Original Formula	K.C. Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All tetrahydrozoline recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile Eye Drops, Original recalled by K.C. PharmaceuticalsGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%) recalledGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
19 Jul 2023Drug	CLASS II	Original Eye Drops recalled by K.C. PharmaceuticalsSunmark Eye Drops Original Formula	K.C. Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
31 Dec 2014Drug	CLASS III	Eye Drops (Tetrahydrozoline HCl 0.05%), Over the Counter recalledSunmark Eye Drops Original Formula	K C Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
26 Nov 2014Drug	CLASS II	Tetrahydrozoline Hydrochloride recalled by Spectrum Laboratory Products	Spectrum Laboratory Products	Manufacturing (CGMP) Deviations	CA

Should you stop taking Tetrahydrozoline?

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.