Loxapine recalls

The FDA has published 8 recalls involving Loxapine since 2012. The latest was reported on 30 May 2018. Most were for manufacturing (cgmp) deviations. Watson Laboratories 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 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 30 May 2018

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 loxapine is recalled

Manufacturing (CGMP) Deviations450%
Packaging Defects450%

Companies

By year

2018450%
2012450%

All loxapine recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
30 May 2018Drug	CLASS II	Loxapine Capsules, USP 25 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
30 May 2018Drug	CLASS II	Loxapine Capsules, USP 25 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
30 May 2018Drug	CLASS II	Loxapine Capsules, USP 50 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
30 May 2018Drug	CLASS II	Loxapine Capsules, USP 50 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
11 Jul 2012Drug	CLASS III	Loxapine Capsules USP, 25mg recalled by Watson LaboratoriesLoxapine	Watson Laboratories	Packaging Defects	Nationwide
11 Jul 2012Drug	CLASS III	Loxapine Capsules USP, 10mg recalled by Watson LaboratoriesLoxapine	Watson Laboratories	Packaging Defects	Nationwide
11 Jul 2012Drug	CLASS III	Loxapine Capsules USP, 50mg recalled by Watson LaboratoriesLoxapine	Watson Laboratories	Packaging Defects	Nationwide
11 Jul 2012Drug	CLASS III	Loxapine Capsules USP, 5mg recalled by Watson Laboratories	Watson Laboratories	Packaging Defects	Nationwide

Should you stop taking Loxapine?

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.