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Drug FDA Class II Ongoing cGMP deviation

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

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)

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

PHENTERMINE HYDROCHLORIDE · 9680 bottles

NDC: 10702-026, 10702-027, 10702-028, 10702-026-03, 10702-026-01, 10702-026-10, 10702-027-03, 10702-027-01, 10702-027-10, 10702-028-03, 10702-028-01, 10702-028-10
Code info: Lot#: 18350A, 18351A, Exp 6/30/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    May 9, 2025
  2. Published
    May 28, 2025
Recall number
D-0446-2025
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.