Phentermine Hydrochloride Capsule
FDA Recall NDC 10702-028
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Phentermine Hydrochloride (NDC 10702-028). A significant event, classified as Class II, was initiated on May 09, 2025 by Kvk-tech, Inc.. The reported reason for this action was: "cGMP deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP deviations
May 09, 2025
May 28, 2025
9680 bottles
Recall Profile & Regulatory Data
Event ID
96847
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
KVK Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# : 18350A, 18351A, Exp 6/30/2027
Affected Packages Involved in this Recall
10702-026-03Product
10702-026-01Product
10702-026-10Product
10702-027-03Product
10702-027-01Product
10702-027-10Product
10702-028-03Product
10702-028-01Product
10702-028-10Product
August 2017 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Aug 03, 2017
Aug 23, 2017
35,267 bottles
Recall Profile & Regulatory Data
Event ID
77878
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the United States
Termination Date
Dec 04, 2018
Product Description
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
Batch or Lot Expiration Information
Lot# a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
Affected Packages Involved in this Recall
10702-026-03Product
10702-026-01Product
10702-026-10Product
10702-027-03Product
10702-027-01Product
10702-027-10Product
10702-028-03Product
10702-028-01Product
10702-028-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
