The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1239-2015·Announced 2015-07-22

Qualitest Recalls HydrOXYzine Tablets Due to Unreadable Identification Codes

Qualitest Pharmaceuticals is recalling HydrOXYzine Hydrochloride 25 mg tablets because some identification codes are unreadable.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is limited to unreadable identification codes, which is a documentation or labeling defect rather than a direct safety hazard.

Plain-English summary

Qualitest Pharmaceuticals is voluntarily recalling HydrOXYzine Hydrochloride Tablets, USP 25 mg, in 100, 500, and 1000-count bottles. The recall was initiated because the identification codes on some tablets may be unreadable, which could affect the ability to verify the product.

The affected products are distributed nationwide. The recall includes specific lot numbers and expiration dates for the 100-count, 500-count, and 1000-count bottles. The total quantity involved is 47,376 bottles.

Consumers with these products should check their bottles for the specific NDC numbers and lot numbers listed in the recall notice. If the product matches the recalled lots, consumers should contact their pharmacist or Qualitest Pharmaceuticals for instructions on how to return the product or obtain a replacement.

The recalled product

Product
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Prescription Medication
Hazard
Affected units
47,376

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 (13)

  • 100 count (NDC 0603-3968-21)
  • LOTS# T144F13A
  • T130G13B
  • T132G13A
  • exp date 6/15
  • T115D14A
  • exp date 3/16
  • 500 count (NDC 0603-3968-28)
  • LOT# T144F13B exp date 6/15
  • and 1000 count (NDC 0603-3968-32)
  • LOTS # T144F13C
  • T132G13B
  • T115D14B

Distribution

Distributed nationwide across the United States.

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