Class II · Moderate risk
Indomethacin Extended-Release Capsules
cGMP deviations
Indomethacin Extended-Release Capsules USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
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.
Affected NDC
10702-0016-01
Compare with the code on your package — it is the most precise check available.
Drug: Indomethacin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Indomethacin NDC 10702-0016 |
75 mg/1 | Capsule, Extended Release Oral |
KVK-Tech, Inc. | Rx |
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Indomethacin recalls
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Class II · Moderate risk
Indomethacin Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules
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Class II · Moderate risk
Indomethacin 25mg Capsules
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Class II · Moderate risk
Indomethacin Capsules
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Other recalls by KVK Tech, Inc.
All 2025 recalls
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Class I · High risk
Betaxolol Tablets
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Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class III · Low risk
Hydrocodone Bitartrate and Homatropine Methlybromide tablets
Failed Impurities/Degradation Specifications
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