Reported Jun 17, 2015 · Terminated

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech…

Akorn, 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: Akorn, Inc. · 1925 W. Field Court, Suite 300 · Lake Forest, IL · 60045

Is this the product you have?

  • Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
Lot codes and dates
    • Lot# 620984
    • 620987
    • Exp 04/2015
    • 621481
    • 621484
    • 621752
    • 621754 Exp 05/2015
    • 621875
    • 622239 Exp 06/2015
    • 622742
    • 622745
    • 623371 Exp 08/2015
    • 623374
    • 623820
    • 623823 Exp 09/2015
    • 624265
    • 624268 Exp 10/2015
    • 624824
    • 624827 Exp 11/2015
    • 625472
    • 625475 Exp 01/2016
    • 625783
    • 625786
    • 626447
    • 626450 02/2016
    • 627683
    • 627797 Exp 05/2016
    • 627800 Exp 06/2016
    • 629094
    • 629097
    • 629100
    • 629103 Exp 08/2016
    • 629928 Exp 09/2016
    • 629931
    • 630480
    • 630483 Exp 10/2016
    • 630874
    • 630877
    • 631513 Exp 12/2016
Amount recalled
N/A

This recall covers 2 products

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

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Impurities/Degradation Specifications

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 Nov 29, 2017 · Data as of Sep 19, 5:04 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.