Use caution Drug recall · FDA · Published December 11, 2013

KVK-Tech Recalls Hydroxyzine HCl Tablets Due to Manufacturing Issues

KVK-Tech recalls 10mg Hydroxyzine HCl tablets because the active ingredient came from an unapproved source. Check your lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1030-2014Drug KVK-Tech ›

Use caution until it’s fixed

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Take action

Contact the company

Recalling firmKVK-Tech, Inc.110 Terry Dr, Suite 200 · Newtown, PA 18940-3427

✎ GovInfoNow plain-language explainer

KVK-Tech, Inc. is recalling 14,664 bottles of Hydroxyzine HCl Tablets USP 10 mg due to deviations from Good Manufacturing Practices. The specific issue is that the Active Pharmaceutical Ingredient was sourced from an unapproved supplier. This recall affects bottles distributed nationwide to wholesale distributors for retail sale. Read more at govinfonow.com/recall/46369-kvk-tech-inc-recalls-hydroxyzine-hci-tablets-usp-10-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/46369-kvk-tech-inc-recalls-hydroxyzine-hci-tablets-usp-10-mg · Updated October 13, 2026 · FDA enforcement record: FDA #D-1030-2014

Cite this page

“KVK-Tech Recalls Hydroxyzine HCl Tablets Due to Manufacturing Issues.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46369-kvk-tech-inc-recalls-hydroxyzine-hci-tablets-usp-10-mg. Based on FDA recall #D-1030-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1030-2014%22&limit=1).

KVK-Tech, Inc. recalled Hydroxyzine HCl Tablets USP 10 mg, 100 count bottles due to Good Manufacturing Practices deviations involving an Active Pharmaceutical Ingredient from an unapproved source, the FDA said on Dec. 11, 2013.

How to tell if you have it

Brand: KVK-Tech
Product: Hydroxyzine HCl Tablets USP 10 mg
NDC #10702-010-01
Lot #11434, exp. Nov-14
Quantity: 14664 bottles

The hazard

The product has an Active Pharmaceutical Ingredient from an unapproved source, constituting Good Manufacturing Practices deviations, the FDA said.

Context

GovInfoNow's records show KVK Tech, Inc. has 11 other recalls on record since 2015-07-14. Other recent recalls of similar products include KVK Tech recalls 30mg Phentermine Capsules due to manufacturing deviations (2025-05-09), KVK Tech Betaxolol Tablets Recall: Risk of Oxycodone Contamination (2023-09-20), and KVK-Tech Atovaquone Oral Suspension Recall: Unusual Grittiness Complaints (2021-07-02). Other recent recalls of similar products include Wells Pharma Ketamine Injectable Solution Recall: C G M P Deviations (2026-04-01), ANI Pharmaceuticals recalls hydrOXYzine oral solution due to foreign substance (2026-06-02), and Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall: N-Nitroso Impurity Risk (2026-01-21).

How to tell if you have this one

Look for Hydroxyzine HCl Tablets USP 10 mg in 100 count bottles. The manufacturer is KVK-Tech, Inc., located in Newtown, PA. Specifically check for NDC #10702-010-01 and lot number 11434 with an expiration date of Nov-14.

Brand
KVK-Tech
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
NDC
10702-010-01, 10702-010-50, 10702-010-10, 10702-011-01, 10702-011-50, 10702-011-10, 10702-012-01, 10702-012-50, 10702-012-10

Recall number	Product, codes & lots	Quantity
D-1030-2014	HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.; lot #11434, exp. Nov-14	14664 bottles
D-1031-2014	HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.; 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, exp. Dec-14; lot # 11036, exp. Dec-14; lot #11435, exp. Nov-15. NDC: 10702-011-10: 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 #10985, exp. Oct-14; lot #11034, exp. Nov-14; lot #11038, exp. Dec-14; lot #11435, exp. Nov-15. NDC: 10702-011-50: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot # 10789, exp. May-14; lot #10791, exp. Jun-14; lot# 10792, exp. Aug-14; lot # 10983, exp. Sep-14; lot # 10985, exp. Oct-14; lot # 10986, exp. Oct-14; lot # 11037, exp. Dec-14; lot #11435, exp. Nov-15.	249,096 bottles
D-1032-2014	HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.; NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; 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; lot # 11140, exp. Feb-15; lot # 11445, exp. Nov-15. NDC: 10702-012-10: lot # 10679, exp. Jan-14; lot # 10689, exp. Jun-14; lot # 10941, Sep-14; lot #10997; Nov-14; lot #10998, Nov-14; lot # 10999, Nov-14; lot #11445, exp. Nov-15. NDC: 10702-012-50: lot #10678, exp. Jan-14; lot #10689, exp. Jun-14; lot #10855, exp. Jul-14; lot # 10943, exp. Sep-14; lot # 11136, exp. Feb-15; lot #11137, exp. Feb-15; lot# 11445, exp. Nov-15.	104551 bottles

Based on the official FDA remedy

What to do — step by step

Check your medication
Verify if you have Hydroxyzine HCl Tablets USP 10 mg, 100 count bottles manufactured by KVK-Tech, Inc. with lot number 11434.
Contact your pharmacist
If you have the recalled product, consult your healthcare provider or pharmacist for guidance on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Dec 11, 2013Firm started the recall
Jan 22, 2014FDA classified it Class II
Jan 29, 2014Published in FDA’s Enforcement Report
Aug 3, 2015FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How many bottles are being recalled?

A total of 14,664 bottles are included in this recall.

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Link to this recall

<a href="https://govinfonow.com/recall/46369-kvk-tech-inc-recalls-hydroxyzine-hci-tablets-usp-10-mg">KVK-Tech Recalls Hydroxyzine HCl Tablets Due to Manufacturing Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1030-2014 (December 11, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1030-2014 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.