Miracle 8989 maXXzen Platinum capsule Recall: FDA Class I

Why it was recalled

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

Product description

maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028

Lot numbers, UPCs & expiration codes

All lots remaining within expiry.

Where it was sold

USA 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-0635-2021
Classification: Class I
Status: Terminated
Recall initiated: May 18, 2021
FDA report date: Jun 30, 2021
Quantity: Unknown
Recall type: Voluntary: Firm initiated
Recalling firm: Miracle 8989

Original FDA data

Every field from FDA enforcement report D-0635-2021, exactly as published.

Show all FDA fields

City: Dallas
State: TX
Status: Terminated
Country: United States
Event ID: 87981
Address: 2001 W Northwest Hwy
Code information: All lots remaining within expiry.
Postal code: 75220-2350
Report date: Jun 30, 2021
Product type: Drugs
Recall number: D-0635-2021
Classification: Class I
Recalling firm: Miracle 8989
Product quantity: Unknown
Termination date: Jul 12, 2023
Reason for recall: Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Voluntary / mandated: Voluntary: Firm initiated
Product description: maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
Distribution pattern: USA Nationwide
Recall initiation date: May 18, 2021
Initial firm notification: Press Release
Center classification date: Jun 22, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0635-2021, published Jun 30, 2021. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Miracle 8989 maXXzen Platinum 12000 capsule Recall

Summary