The Recall Desk
ModerateFDA (Drugs)·D-1032-2014·Announced 2014-01-29

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

KVK-Tech, Inc. is recalling 104,551 bottles of Hydroxyzine Hydrochloride 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 is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a GMP deviation regarding the source of the API, which is a quality issue rather than a direct toxicological threat like a high-risk pathogen or structural defect.

Plain-English summary

KVK-Tech, Inc. is recalling 104,551 bottles of Hydroxyzine Hydrochloride tablets in 50 mg strengths. The affected products are available in 100, 500, and 1000-count bottles and are prescription-only. The recall covers specific lots identified by NDC codes 10702-012-01, 10702-012-50, and 10702-012-10.

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 affects the integrity of the drug product but does not indicate a specific contamination or adulteration with a harmful substance in the traditional sense.

The affected products were distributed nationwide, including Puerto Rico, to wholesale distributors for sale to retail establishments. Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC codes listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for credit or replacement.

The recalled product

Product
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
Brand
HYDROXYZINE HYDROCHLORIDE
Manufacturer
KVK-Tech, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
104,551

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 10702-012-01: lot # 10667
  • Jan-14
  • lot # 10677
  • exp. Jan-14
  • lot # 10679
  • lot# 10688
  • exp. May-14
  • lot #10693
  • exp. Jul-14
  • lot #10854
  • Jul-14
  • lot # 10942
  • exp. Sep-14
  • lot #10995
  • exp.Oct-14
  • lot # 10996
  • Nov-14
  • lot #11138
  • exp. Feb-15
  • lot # 11139 Feb-15

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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