Recall: D-0445-2025

Class II - Potentially Harmful

Class IIClassification

2025-05-09Initiated

OngoingStatus

KVK Tech, Inc.Firm

Product

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.

Reason

cGMP deviations

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.