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.

FDA recall notice · announced May 28, 2025 · Kvk Tech

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

cGMP deviations

Notes

Distribution: Nationwide
Lot/code information: Lot#: 18400A, Exp 7/31/2027
Quantity: 9107 bottles
Status: Ongoing
Products in this recall event:
- 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. (D-0446-2025)
- 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. (D-0445-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.