One and Zen Ginseng Kianpi PIL Recall: FDA Class II

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

Product description

GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0329-2015
Classification: Class II
Status: Terminated
Recall initiated: Nov 20, 2014
FDA report date: Jan 7, 2015
Quantity: 38 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: One and Zen

Original FDA data

Every field from FDA enforcement report D-0329-2015, exactly as published.

Show all FDA fields

City: Albuquerque
State: NM
Status: Terminated
Country: United States
Event ID: 69836
Address: 1339 San Mateo Blvd Se
Address (line 2): Apt 2
Code information: All lots
Postal code: 87108-4697
Report date: Jan 7, 2015
Product type: Drugs
Recall number: D-0329-2015
Classification: Class II
Recalling firm: One and Zen
Product quantity: 38 bottles
Termination date: Mar 23, 2015
Reason for recall: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Voluntary / mandated: Voluntary: Firm initiated
Product description: GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
Distribution pattern: Nationwide
Recall initiation date: Nov 20, 2014
Initial firm notification: E-Mail
Center classification date: Dec 30, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0329-2015, published Jan 7, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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One and Zen Ginseng Kianpi Pil Recall

Summary