Indomethacin Extended-Release Capsules USP recalled over manufacturing violations
- Recall date
- May 9, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- KVK Tech, Inc. recalls Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 189…
- Recall number
- D-0445-2025
- FDA classification
- Class II
- Brand / firm
- KVK Tech, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
cGMP deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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