The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-603-2013·Announced 2013-06-26

Hi-Tech Pharmacal Recalls Subpotent HydrOXYzine Hydrochloride Oral Solution

Hi-Tech Pharmacal is recalling specific lots of HydrOXYzine Hydrochloride Oral Solution because the product failed stability testing and may be subpotent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which indicates a low risk of adverse health consequences. The hazard is a subpotent medication, which is a quality issue rather than a direct safety hazard like contamination or injury.

Plain-English summary

Hi-Tech Pharmacal Co., Inc. is recalling HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only. The recall involves two specific lots: Batch 608917 (expiration date 02/2014) and Batch 608204 (expiration date 01/2014). The total quantity recalled is 15,240 bottles.

The reason for the recall is that the product failed a 24-month stability test station, resulting in a subpotent classification. This means the medication may not contain the full labeled amount of the active ingredient. The affected products were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the recalled 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, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
Manufacturer
Hi-Tech Pharmacal Co., Inc.
Category
Drug — Antihistamine
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 (2)

  • Batch 608917 (exp. 02/2014)
  • and Batch 608204 (exp. 01/2014)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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