Tramadol recalls

The FDA has published 9 recalls involving Tramadol since 2012. The latest was reported on 8 Apr 2026. The Harvard Drug Group 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 recalls9since 2012

Last 12 months1reported

Class I00% of total

Ongoing2latest 8 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 1 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 7 78%Class III 2 22%

Why tramadol is recalled

Companies

By year

2026111%
2024222%
2023111%
2021111%
2020111%
2018111%
2014111%
2012111%

Ongoing tramadol recalls

2 active

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	traMADol Hydrochloride Tablets, USP, 50 mg recalled	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
15 May 2024Drug	CLASS II	traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride	Rubicon Research Private	Other	Nationwide

All tramadol recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	traMADol Hydrochloride Tablets, USP, 50 mg recalled	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
15 May 2024Drug	CLASS II	traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride	Rubicon Research Private	Other	Nationwide
15 May 2024Drug	CLASS II	TraMADol HCl, Packaged as (a) recalled by RemedyRepack	RemedyRepack	Packaging Defects	Nationwide
5 Jul 2023Drug	CLASS II	Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose Tablets recalled	The Harvard Drug Group	Packaging Defects	Nationwide
2 Jun 2021Drug	CLASS II	Tramadol Hydrochloride Tablets USP 100mg recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
4 Mar 2020Drug	CLASS III	Tramadol Hydrochloride Tablets, USP, 50 mg recalled	Golden State Medical Supply	Packaging Defects	Nationwide
18 Apr 2018Drug	CLASS III	Tramadol Hydrochloride recalled by Lake Erie Medical & Surgical	Lake Erie Medical & Surgical Supply	Other	FL, VA
22 Jan 2014Drug	CLASS II	traMADol HCl Tablet, 25 mg (1/2 of 50 mg) recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
12 Dec 2012Drug	CLASS II	traMADOL Hydrochloride Tablets recalled by Caraco Pharmaceutical	Caraco Pharmaceutical Laboratories	Other	Nationwide

Should you stop taking Tramadol?

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.