Sotalol recalls

The FDA has published 4 recalls involving Sotalol since 2014. The latest was reported on 25 Mar 2020. Most were for labeling errors. Aidapak Services 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 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 25 Mar 2020

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 0 0%Class II 4 100%Class III 0 0%

Why sotalol is recalled

Labeling Errors375%
Particulate Matter125%

Companies

Aidapak Services375%
Mylan Pharmaceuticals125%

By year

2020125%
2014375%

All sotalol recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
25 Mar 2020Drug	CLASS II	Sotalol HCL Tablets, USP (AF) 80 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Particulate Matter	Nationwide
29 Jan 2014Drug	CLASS II	Sotalol HCL, Tablet, 120 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Sotalol HCL, Tablet, 160 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Sotalol HCL, Tablet, 80 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Sotalol?

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.