Amitriptyline recalls

The FDA has published 2 recalls involving Amitriptyline since 2017. The latest was reported on 30 Aug 2017. Most were for packaging defects. C. O. Truxton 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 recalls2since 2017

Last 12 months0reported

Class I00% of total

Ongoing0latest 30 Aug 2017

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 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 1 50%Class III 1 50%

Why amitriptyline is recalled

Packaging Defects150%
Labeling Errors150%

Companies

C. O. Truxton150%
Sandoz150%

By year

20172100%

All amitriptyline recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
30 Aug 2017Drug	CLASS II	Amitriptyline HCL Tablets, USP 50 mg recalled by C. O. Truxton	C. O. Truxton	Labeling Errors	Nationwide
12 Jul 2017Drug	CLASS III	Amitriptyline HCl Tablets, USP 25 mg recalled by Sandoz IncorporatedAmitriptyline Hydrochloride	Sandoz	Packaging Defects	Nationwide

Should you stop taking Amitriptyline?

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.