The Recall Desk
SevereFDA (Drugs)·D-1031-2014·Announced 2014-01-29

KVK-Tech Recalls Hydroxyzine Hydrochloride Tablets Due to Unapproved Ingredient Source

KVK-Tech, Inc. is recalling 249,096 bottles of Hydroxyzine Hydrochloride tablets because the active pharmaceutical ingredient was sourced from an unapproved supplier.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.

Plain-English summary

KVK-Tech, Inc. is recalling 249,096 bottles of Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) tablets, USP 25 mg. The affected products are prescription-only and are available in 100, 500, and 1000-count bottles. The recall was initiated due to Good Manufacturing Practices deviations, specifically because the product contains an Active Pharmaceutical Ingredient (API) from an unapproved source.

The recalled products were distributed nationwide, including Puerto Rico, to wholesale distributors for sale to retail establishments. Specific lot numbers and expiration dates are listed in the official recall notice, covering NDCs 10702-011-01, 10702-011-50, and 10702-011-10.

Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for disposal or credit. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
Brand
HYDROXYZINE HYDROCHLORIDE
Manufacturer
KVK-Tech, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
249,096

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)

  • NDC: 10702-011-01: lot #10666
  • exp. Feb-14
  • lot #10733
  • exp. May-14
  • lot # 10789
  • exp.May-14
  • lot #10790
  • exp. Jun-14
  • lot # 10791
  • exp. Jun-14: lot # 10792
  • exp. Aug-14
  • lot #10983
  • exp. Sep-14
  • lot #10984
  • exp.Sep-14
  • lot #10986
  • exp. Oct-14
  • lot # 11034
  • exp. Nov-14
  • lot #11035

UPCs (1)

  • 0310702012103

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 3 recalled by KVK-Tech, 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 3 products in this recall →

Related recalls

Same brand · HYDROXYZINE HYDROCHLORIDE

Same manufacturer · KVK-Tech, Inc.

See all →

Same hazard · unapproved ingredient source

See all →