Indomethacin Extended-Release Capsules USP recall
FDA recall D-0445-2025 · initiated May 9, 2025
KVK Tech, Inc. recalled Indomethacin Extended-Release Capsules USP in May 2025 — an FDA Class II recall (D-0445-2025) because cGMP deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 9107 bottles
Details
- 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.
- Recalling company
- Kvk Tech Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- May 9, 2025
- FDA report date
- May 28, 2025
Frequently asked
- Was Indomethacin Extended-Release Capsules USP recalled?
- KVK Tech, Inc. recalled Indomethacin Extended-Release Capsules USP in May 2025 — an FDA Class II recall (D-0445-2025) because cGMP deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Indomethacin Extended-Release Capsules USP recalled?
- Per the FDA enforcement record, the reason for recall D-0445-2025 was: cGMP deviations
- Is a recalled Indomethacin Extended-Release Capsules USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Indomethacin Extended-Release Capsules USP are affected?
- Distributed: Nationwide. The recall covers these lots — Lot#: 18400A, Exp 7/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0445-2025.