Reported May 30, 2018 · Terminated

Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01

Mylan Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730

Is this the product you have?

    • Loxapine Capsules
    • USP 50 mg
    • Rx Only
    • 100-count bottles
    • NDC 0378-7050-01
Lot codes and dates
  • NDC 0378-7050-01 Lot Numbers
    • 3079386
    • Exp. 10/31/18 3079387
    • Exp. 10/31/18 3079388
    • Exp. 10/31/18 3083762
    • Exp. 3/31/19 3083763
    • Exp. 3/31/19 3083764
    • Exp. 3/31/19 3083765
    • Exp. 3/31/19 3083766
    • Exp. 3/31/19 3083767
    • Exp. 3/31/19
Amount recalled
11,650 bottles

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 14, 2019 · Data as of Sep 19, 7:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.