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Drug FDA Class II Ongoing cGMP deviation

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.

KVK Tech, Inc. Published May 28, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact KVK Tech, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP deviations

Affected products (1)

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.

INDOMETHACIN · 9107 bottles

NDC: 10702-016, 10702-016-03, 10702-016-06, 10702-016-09, 10702-016-01, 10702-016-50, 10702-016-10
Code info: Lot#: 18400A, Exp 7/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    May 9, 2025
  2. Published
    May 28, 2025
Recall number
D-0445-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.