Quetiapine recalls

The FDA has published 8 recalls involving Quetiapine since 2013. The latest was reported on 18 Mar 2020. Most were for packaging defects. 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 recalls8since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 18 Mar 2020

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 0 0%Class II 4 50%Class III 4 50%

Why quetiapine is recalled

Companies

By year

2020450%
2018113%
2014225%
2013113%

All quetiapine recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
18 Mar 2020Drug	CLASS III	Quetiapine Fumarate Extended-Release Tablets, 50 mg per unit dose recalledQuetiapine	The Harvard Drug Group	Packaging Defects	Nationwide
18 Mar 2020Drug	CLASS III	Quetiapine Fumarate Extended-Release Tablets, 200 mg per unit dose recalledQuetiapine	The Harvard Drug Group	Packaging Defects	Nationwide
18 Mar 2020Drug	CLASS III	Quetiapine Fumarate Extended-Release Tablets, 300 mg per unit dose recalledQuetiapine	The Harvard Drug Group	Packaging Defects	Nationwide
18 Mar 2020Drug	CLASS III	Quetiapine Fumarate Extended-Release Tablets, 150 mg per unit dose recalledQuetiapine	The Harvard Drug Group	Packaging Defects	Nationwide
5 Dec 2018Drug	CLASS II	Quetiapine Tablets USP 400 mg recalled by Ascend LaboratoriesQuetiapine	Ascend Laboratories	Foreign Material	Nationwide
22 Jan 2014Drug	CLASS II	QUEtiapine Fumarate Tablet, 100 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Quetiapine Fumarate Tablet, 5 mg (1/2 of 25 mg) recalled	Aidapak Services	Labeling Errors	4 states
24 Jul 2013Drug	CLASS II	Quetiapine Fumarate Tablets 25mg Blister card, Rx, Packaged recalled	American Health Packaging	Potency & Assay	Nationwide

Should you stop taking Quetiapine?

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.