Drug Recalled for Failing Dissolution Testing

Glenmark Pharmaceuticals Inc. USA is recalling 2404 bottles of indomethacin extended-release capsules distributed throughout the United States by Taro Pharmaceuticals USA, Hawthorne, New York. According to the September 4, 2024, US Food and Drug Administration (FDA) Enforcement Report, samples failed to meet dissolution specifications during testing.

The recall affects indomethacin extended-release capsules, 75 mg, in 60-count (NDC 68462-325-60) and 90-count bottles (NDC 68462-325-90) from lot 17240105 (Exp. 12/31/25). The capsules were manufactured by Glenmark Pharmaceuticals Limited, Madhya Pradesh, India, for Glenmark Pharmaceuticals Inc. USA, Mahwah, New Jersey.

Glenmark Pharmaceuticals Inc. USA voluntarily initiated the recall on July 31, 2024. The FDA designated the recall Class II on August 23, 2024. Per the classification, use of the drug could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug available with a prescription for patients with rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, and acute shoulder pain.