KVK Tech, Inc.: Drug Recall

Recall #D-0445-2025 · 05/09/2025

Class II: Risk

Recall Details

Recall Number: D-0445-2025
Classification: Class II
Product Type: Drug
Recalling Firm: KVK Tech, Inc.
Status: Ongoing
Date Initiated: 05/09/2025
Location: Newtown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9107 bottles

Reason for Recall

cGMP deviations

Product Description

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.

Distribution Pattern

Nationwide

Other Recalls by KVK Tech, Inc.

Class II: Risk 05/09/2025

cGMP deviations
Class I: Dangerous 09/20/2023

Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I: Dangerous 07/02/2021

Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class III: Low Risk 04/27/2021

Failed Impurities/Degradation Specifications
Class III: Low Risk 12/18/2020

Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A

View all recalls by KVK Tech, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.