The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1129-2015·Announced 2015-06-17

Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurity Failures

Akorn, Inc. is recalling 424,174 bottles of Hydroxyzine Hydrochloride oral solution because the product failed impurities and degradation specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any specific illnesses, injuries, or deaths, and the hazard is a failure of impurities/degradation specifications rather than a high-risk pathogen or structural defect.

Plain-English summary

Akorn, Inc. is recalling 424,174 bottles of Hydroxyzine Hydrochloride oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottles. The product is prescription-only and was manufactured for KVK-Tech, Inc. by Hi-Tech Pharmacal Co., Inc.

The recall was initiated because the product failed impurities and degradation specifications. The affected lots include 621637, 621640, 622748, 622751, 623599, 623602, 624132, 624135, 628282, 628285, 628288, 628291, 628850, 628853, 628856, 628859, 629797, 629800, 629803, and 629806, with expiration dates ranging from May 2015 to September 2016.

The product was distributed nationwide, including Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
Manufacturer
Akorn, Inc.
Category
Drug — Oral Solution
Hazard
Affected units
424,174

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot# 621637
  • 621640 Exp 05/2015
  • 622748
  • 622751 Exp 08/2015
  • 623599
  • 623602 Exp 09/2015
  • 624132
  • 624135 Exp 10/2015
  • 628282
  • 628285
  • 628288
  • 628291 Exp 06/2016
  • 628850
  • 628853
  • 628856
  • 628859 Exp 07/2016
  • 629797
  • 629800
  • 629803
  • 629806 Exp 09/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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