The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1130-2015·Announced 2015-06-17

Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities

Akorn, Inc. is recalling Hydroxyzine Hydrochloride oral solution because it failed impurities and degradation specifications. The product was distributed nationwide, including Puerto Rico.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), particularly when associated with significant quality failures like impurities.

Plain-English summary

Akorn, Inc. is recalling Hydroxyzine Hydrochloride oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottles. The recall was initiated because the product failed impurities and degradation specifications. The medication is prescription-only and was manufactured by Hi-Tech Pharmacal Co., Inc.

The affected product was distributed nationwide, including Puerto Rico. Specific lot numbers and expiration dates are listed in the recall documentation, ranging from April 2015 to December 2016. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
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
Manufacturer
Akorn, Inc.
Category
Drug — Oral Solution
Hazard

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# 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

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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