KVK-Tech, Inc.

• Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 8 products
• MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 7 products
• Phentermine hydrochlorideLomaira · 7 products
• Hydrocodone bitartrate and acetaminophenNorco · 6 products
• Oxycodone and acetaminophenEndocet, Prolate, Percocet · 5 products
• Phendimetrazine tartrate3 products
• Promethazine hydrochloridePhenergan, Promethegan · 3 products
• Dexmethylphenidate hydrochlorideFocalin XR, Focalin · 3 products
• Hydroxyzine3 products
• Desmopressin acetateDdavp, Stimate, Desmoda · 2 products
• LeflunomideArava · 2 products
• Oxymorphone hydrochloride2 products
• Betaxolol hydrochlorideBetoptic S · 2 products
• Hydrocodone bitartrate and homatropine methylbromide2 products
• Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 2 products
• DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 2 products
• IndomethacinIndocin · 1 product
• Butalbital, acetaminophen and caffeineFioricet · 1 product
• Isoproterenol hydrochloride1 product
• Sodium polystyrene sulfonateKionex · 1 product
• UrsosiolUrsodiol · 1 product
• OxybutyninOxytrol · 1 product
• AtovaquoneMepron · 1 product
• CyclosporineSandimmune, Neoral, Cyclosporine Modified · 1 product
• Benzphetamine hydrochloride1 product
• Diethylpropion hydrochloride1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2026

1. January 14, 2026 · Class II · Ongoing · D-0338-2026 · Oxycodone hydrochloride

   Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

   Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health P

2025

1. May 9, 2025 · Class II · Ongoing · D-0445-2025 · Indomethacin

   cGMP deviations

   Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.

2. May 9, 2025 · Class II · Ongoing · D-0446-2025 · Phentermine hydrochloride

   cGMP deviations

   Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

2023

1. September 20, 2023 · Class I · Terminated · D-0049-2024 · Betaxolol hydrochloride

   Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

   Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.

2021

1. July 2, 2021 · Class I · Terminated · D-0772-2021 · Atovaquone

   Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

   Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.

2. April 27, 2021 · Class III · Terminated · D-0386-2021 · Hydrocodone bitartrate and homatropine methylbromide

   Failed Impurities/Degradation Specifications

   Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03

2019

1. November 1, 2019 · Class II · Terminated · D-0532-2020 · Hydrocodone bitartrate and homatropine methylbromide

   Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

   Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16

2018

1. December 11, 2018 · Class II · Terminated · D-0340-2019 · Oxybutynin

   Labeling: Wrong bar code

   Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50

2017

1. August 3, 2017 · Class III · Terminated · D-1083-2017 · Phentermine hydrochloride

   Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.

   Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940

2013

1. December 11, 2013 · Class II · Terminated · D-1032-2014 · Hydroxyzine

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

   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.

2. December 11, 2013 · Class II · Terminated · D-1031-2014 · Hydroxyzine

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

   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.

3. December 11, 2013 · Class II · Terminated · D-1030-2014 · Hydroxyzine

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

   HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →