Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Loxapine Capsules Recalled by Mylan Pharmaceuticals Inc. Due to CGMP Deviations

Date: April 24, 2018
Company: Mylan Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Pharmaceuticals Inc. directly.

Affected Products

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

Quantity: 8,679 bottles

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

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

About Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report