Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

KVK Tech, Inc.

NDC code

10702-016-01

Origin

PA, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0445-2025

Other Indomethacin recalls

See all

Class II · Moderate risk Ongoing May 15, 2025

Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by…

Reason cGMP deviations

Amerisource Health Services LLC NDC 68084-411-21 D-0454-2025

Class II · Moderate risk Ongoing Mar 13, 2025

Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 68462-325-60 D-0329-2025

Class II · Moderate risk Ongoing Jul 31, 2024

Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle…

Reason Failed Dissolution Specifications: below specification results

Glenmark Pharmaceuticals Inc., USA NDC 68462-325-60 D-0643-2024

Class II · Moderate risk Ongoing Nov 7, 2023

Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa…

Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Glenmark Pharmaceuticals Inc., USA NDC 68462-406-01 D-0123-2024

Class II · Moderate risk Terminated Jul 18, 2018

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ…

Reason Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

Hetero Labs, Ltd. - Unit III NDC 31722-543-01 D-1019-2018