Lurasidone recalls

The FDA has published 3 recalls involving Lurasidone since 2014. The latest was reported on 31 Jan 2024. Most were for sterility. SUN Pharmaceutical Industries 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 recalls3since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 31 Jan 2024

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 3 100%Class III 0 0%

Why lurasidone is recalled

Sterility267%
Labeling Errors133%

Companies

SUN Pharmaceutical Industries267%
Aidapak Services133%

By year

2024267%
2014133%

All lurasidone recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
31 Jan 2024Drug	CLASS II	Lurasidone Hydrochloride Tablets 120mg recalledLurasidone Hydrochloride	SUN Pharmaceutical Industries	Sterility	Nationwide
31 Jan 2024Drug	CLASS II	Lurasidone Hydrochloride Tablets 60mg recalledLurasidone Hydrochloride	SUN Pharmaceutical Industries	Sterility	Nationwide
22 Jan 2014Drug	CLASS II	Lurasidone HCL, Tablet, 120 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Lurasidone?

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.