Digoxin recalls

The FDA has published 6 recalls involving Digoxin since 2014. The latest was reported on 24 Apr 2024. Most were for labeling errors. Novitium Pharma 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 recalls6since 2014

Last 12 months0reported

Class I117% of total

Ongoing0latest 24 Apr 2024

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 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 17%Class II 3 50%Class III 2 33%

Why digoxin is recalled

Companies

By year

2024233%
2023233%
2014233%

All digoxin recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
24 Apr 2024Drug	CLASS III	Digoxin Tablets, USP 62.5 mcg (0.0625 mg) recalled by Novitium PharmaDigoxin	Novitium Pharma	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS III	Digoxin Tablets, USP 125mcg, (0.125 mg) recalled by Novitium PharmaDigoxin	Novitium Pharma	Other	Nationwide
13 Sep 2023Drug	CLASS I	Digoxin Tablets, USP 0.125mg recalled by Marlex Pharmaceuticals	Marlex Pharmaceuticals	Packaging Defects	Nationwide
13 Sep 2023Drug	CLASS II	Digoxin Tablets, USP 0.25mg recalled by Marlex Pharmaceuticals	Marlex Pharmaceuticals	Packaging Defects	Nationwide
29 Jan 2014Drug	CLASS II	Digoxin, Tablet, 125 mcg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Digoxin, Tablet, 0.125 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Digoxin?

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.