CLASS II Drug recall · Reported 30 May 2018 · FDA Enforcement Report

Loxapine Capsules, USP 25 mg recalled by Mylan Pharmaceuticals

Mylan Pharmaceuticals is recalling Loxapine Capsules, USP 25 mg, distributed nationwide in the US. The recall was initiated on 24 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp. 3/31/19 3083760, Exp. 3/31/19 3083761, Exp. 3/31/19

Quantity recalled8,679 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0824-2018
FDA event ID: 79955
Recalling firm: Mylan Pharmaceuticals, Morgantown, WV
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2018
FDA classified: 22 May 2018
Reported: 30 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

24 Apr 2018	Recall initiated by company
22 May 2018	Classified by FDA	+28 days
30 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations

Product as listed by the FDA

Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

Where it was distributed

Product was distributed throughout the United States, including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

CGMP Deviations

Which lots are affected?

NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp. 3/31/19 3083760, Exp. 3/31/19 3083761, Exp. 3/31/19

Where was it sold?

Product was distributed throughout the United States, including Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79955

This product is part of a recall event; the main page for the event is Loxapine Capsules, USP 50 mg recalled by Mylan Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
30 May 2018	CLASS II	Loxapine Capsules, USP 50 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Mylan Pharmaceuticals

All 84

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Potency & Assay	Nationwide
26 Aug 2026Drug	CLASS II	Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium	Mylan Pharmaceuticals	Potency & Assay	Nationwide
5 Aug 2026Drug	CLASS II	Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Other	Nationwide
11 Mar 2026Drug	CLASS II	Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem	Mylan Pharmaceuticals	Potency & Assay	Nationwide

Other Loxapine recalls

All 9

Reported	Class	Recall	Company	Reason	Where
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
29 Jan 2014Drug	CLASS II	Loxapine, Capsule, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
11 Jul 2012Drug	CLASS III	Loxapine Capsules USP, 25mg recalled by Watson LaboratoriesLoxapine	Watson Laboratories	Packaging Defects	Nationwide