← FDA ENFORCEMENT
D-0446-2025Class II
KVK Tech, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
KVK Tech, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-05-28
Distribution
Nationwide
Firm state
PA
Product quantity
9680 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP deviations
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.
Code / lot info
Lot#: 18350A, 18351A, Exp 6/30/2027
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See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →