Digoxin recalls

The FDA has published 4 recalls involving Digoxin since 2023. The latest was reported on 24 Apr 2024. Most were for packaging defects. Marlex Pharmaceuticals 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 recalls4since 2023

Last 12 months0reported

Class I125% of total

Ongoing0latest 24 Apr 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 25%Class II 1 25%Class III 2 50%

Why digoxin is recalled

Companies

Marlex Pharmaceuticals250%
Novitium Pharma250%

By year

2024250%
2023250%

All digoxin recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
24 Apr 2024Drug	CLASS III	Digoxin Tablets, USP 5 mcg 0625 mg) recalled by Novitium PharmaDigoxin	Novitium Pharma	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS III	Digoxin Tablets, USP 125mcg, 125 mg) recalled by Novitium PharmaDigoxin	Novitium Pharma	Other	Nationwide
13 Sep 2023Drug	CLASS I	Digoxin Tablets, USP 125mg recalled by Marlex Pharmaceuticals	Marlex Pharmaceuticals	Packaging Defects	Nationwide
13 Sep 2023Drug	CLASS II	Digoxin Tablets, USP 25mg recalled by Marlex Pharmaceuticals	Marlex Pharmaceuticals	Packaging Defects	Nationwide

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.