The Recall Desk
ModerateFDA (Drugs)·D-1030-2014·Announced 2014-01-29

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

KVK-Tech, Inc. is recalling 14,664 bottles of Hydroxyzine Hydrochloride 10 mg tablets because the active ingredient came from an unapproved source.

What this means for you

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 typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or fatalities, and the hazard is related to manufacturing compliance (unapproved source) rather than a confirmed toxicological event, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

KVK-Tech, Inc. is recalling 14,664 bottles of Hydroxyzine Hydrochloride 10 mg tablets (NDC #10702-010-01). The affected product is Lot #11434, with an expiration date of November 2014. The bottles contain 100 tablets each and are prescription-only.

The recall was initiated due to Good Manufacturing Practices deviations. Specifically, the product contains an Active Pharmaceutical Ingredient (API) from an unapproved source. This issue was identified by the U.S. Food and Drug Administration.

The affected product was distributed nationwide, including Puerto Rico, to wholesale distributors for sale to retail establishments. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for disposal or credit, as directed by the recalling firm.

The recalled product

Product
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
Brand
HYDROXYZINE HYDROCHLORIDE
Manufacturer
KVK-Tech, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
14,664

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)

  • lot #11434
  • exp. Nov-14

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.

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Same hazard · gmp deviation

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