Clonidine recalls

The FDA has published 23 recalls involving Clonidine since 2013. The latest was reported on 15 Apr 2026. Most were for manufacturing (cgmp) deviations. Coast Quality Pharmacy 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 recalls23since 2013

Last 12 months3reported

Class I00% of total

Ongoing3latest 15 Apr 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 3 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 17 74%Class III 6 26%

Why clonidine is recalled

Companies

Coast Quality Pharmacy522%
Teva Pharmaceuticals USA417%
Unichem Pharmaceuticals USA313%
Mutual Pharmaceutical313%
Mckesson Medical-Surgical Inc. Corporate Office29%
X-Gen Pharmaceuticals29%
Mayne Pharma14%
PD-Rx Pharmaceuticals14%

Brands

By year

2026313%
2022417%
202114%
202029%
2019626%
201614%
2015313%
201429%
201314%

Ongoing clonidine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	Clonidine Transdermal System, USP, 0.3 mg/day, supplied recalledClonidine Transdermal System	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	NJ
15 Apr 2026Drug	CLASS II	Clonidine Transdermal System, USP, 0.1 mg/day, supplied recalledClonidine Transdermal System	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	NJ
15 Apr 2026Drug	CLASS II	Clonidine Transdermal System, USP, 0.2 mg/day, supplied recalledClonidine Transdermal System	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	NJ

All clonidine recalls, newest first

23 total

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	Clonidine Transdermal System, USP, 0.3 mg/day, supplied recalledClonidine Transdermal System	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	NJ
15 Apr 2026Drug	CLASS II	Clonidine Transdermal System, USP, 0.1 mg/day, supplied recalledClonidine Transdermal System	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	NJ
15 Apr 2026Drug	CLASS II	Clonidine Transdermal System, USP, 0.2 mg/day, supplied recalledClonidine Transdermal System	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	NJ
28 Sep 2022Drug	CLASS III	Clonidine Hydrochloride Tablets, USP, 0.3 mg recalledClonidine Hydrochloride	Unichem Pharmaceuticals USA	Packaging Defects	Nationwide
29 Jun 2022Drug	CLASS II	Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches recalledClonidine	Mayne Pharma	Potency & Assay	Nationwide
15 Jun 2022Drug	CLASS II	Clonidine Hydrochloride Tablets, USP, 0.1 mg recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Duraclon (clonidine HCl injection, USP), 1000 mcg recalledDuraclon	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
24 Nov 2021Drug	CLASS III	Clonidine Transdermal System, USP 0.1 mg/day, 4 patches recalledClonidine Transdermal System	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
17 Jun 2020Drug	CLASS III	Clonidine Hydrochloride Tablets, USP 0.1 mg recalledClonidine Hydrochloride	Unichem Pharmaceuticals USA	Potency & Assay	Nationwide
12 Feb 2020Drug	CLASS III	Clonidine Hydrochloride Tablets, USP 0.1mg recalledClonidine Hydrochloride	Unichem Pharmaceuticals USA	Potency & Assay	Nationwide
18 Dec 2019Drug	CLASS II	Clonidine HCL and Baclofen and Fentanyl Citrate recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019Drug	CLASS II	Clonidine HCL and Baclofen in all strengths, all doses recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019Drug	CLASS II	Clonidine HCL/Hydromorphone HCL in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019Drug	CLASS II	Clonidine HCL in all strengths, all doses and all packaging recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019Drug	CLASS II	Clonidine HCL and Morphine Sulfate in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
17 Apr 2019Drug	CLASS III	Clonidine HCL Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalledClonidine	X-Gen Pharmaceuticals	Other	Nationwide
6 Jan 2016Drug	CLASS II	Clonidine Hydrochloride Tablets, USP, 0.1 mg recalled	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	AL
5 Aug 2015Drug	CLASS II	Clonidine Hydrochloride Tablets, USP, 0.2 mg recalled	Mutual Pharmaceutical	Manufacturing (CGMP) Deviations	PA
5 Aug 2015Drug	CLASS II	Clonidine Hydrochloride Tablets, USP, 0.1 mg recalled	Mutual Pharmaceutical	Manufacturing (CGMP) Deviations	PA
5 Aug 2015Drug	CLASS II	Clonidine Hydrochloride Tablets, USP, 0.3 mg HDPE recalled	Mutual Pharmaceutical	Manufacturing (CGMP) Deviations	PA
22 Oct 2014Drug	CLASS II	Clonidine HCL recalled by Gyma Laboratories Of Amer	Gyma Laboratories Of Amer	Manufacturing (CGMP) Deviations	Nationwide
30 Jul 2014Drug	CLASS III	Clonidine HCl Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalledClonidine	X-Gen Pharmaceuticals	Other	Nationwide
9 Jan 2013Drug	CLASS II	Clonidine 100 mcg/mL PF and vials recalled	New England Compounding Center	Sterility	Nationwide

Should you stop taking Clonidine?

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.