FDAClass IIMay 28, 2025

Indomethacin Extended-Release Capsules USP recall: 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…

Why was Indomethacin Extended-Release Capsules USP recalled?

cGMP deviations

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 18400A, Exp 7/31/2027

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…
Recalling firm
KVK Tech, Inc.
Quantity
9107 bottles
Distribution
Nationwide
Recall date
May 28, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls