Clonazepam recalls

The FDA has published 10 recalls involving Clonazepam since 2014. The latest was reported on 15 Jan 2025. Most were for labeling errors. Endo USA 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 recalls10since 2014

Last 12 months0reported

Class I550% of total

Ongoing4latest 15 Jan 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 4 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 5 50%Class II 2 20%Class III 3 30%

Why clonazepam is recalled

Labeling Errors660%
Potency & Assay440%

Companies

Endo USA440%
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)330%
Endo Pharmaceuticals110%
Actavis Elizabeth110%
Aidapak Services110%

By year

2025440%
2024110%
2016330%
2014220%

Ongoing clonazepam recalls

4 active

Reported	Class	Recall	Company	Reason	Where
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide

All clonazepam recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
7 Aug 2024Drug	CLASS I	Clonazepam Orally Disintegrating Tablets recalledClonazepam	Endo Pharmaceuticals	Labeling Errors	Nationwide
16 Nov 2016Drug	CLASS III	Clonazepam Tablets, USP, 0.5 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
16 Nov 2016Drug	CLASS III	Clonazepam Tablets, USP, 1.0 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
10 Feb 2016Drug	CLASS III	Clonazepam Tablets, USP, 0.5 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
5 Mar 2014Drug	CLASS II	Clonazepam Tablets, USP 2 mg recalled by Actavis Elizabeth	Actavis Elizabeth	Potency & Assay	Nationwide
29 Jan 2014Drug	CLASS II	clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg) recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Clonazepam?

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.