Stop using now Drug recall · FDA · Published May 18, 2021

PremierZEN Platinum 8000 Recall: Tainted with Sildenafil and Tadalafil

FDA recalls PremierZEN Platinum 8000 capsules distributed by New Premier Group. Product is tainted with undeclared drugs Sildenafil and Tadalafil.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0634-2021Drug PremierZEN ›

Stop using this now

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

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Contact the company

Recalling firmMiracle 89892001 W Northwest Hwy · Dallas, TX 75220-2350

✎ GovInfoNow plain-language explainer

The FDA has issued a Class I recall for PremierZEN Platinum 8000 capsules because they are marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product was found to be tainted with the active ingredients Sildenafil and Tadalafil. These undeclared drugs can cause serious health risks, particularly for people taking nitrates for chest pain. Read more at govinfonow.com/recall/36133-premierzen-platinum-8000-recall-tainted-with-sildenafil-and-tadalafil.

Source Summary by GovInfoNow · govinfonow.com/recall/36133-premierzen-platinum-8000-recall-tainted-with-sildenafil-and-tadalafil · Updated October 10, 2026 · FDA enforcement record: FDA #D-0634-2021

Cite this page

“PremierZEN Platinum 8000 Recall: Tainted with Sildenafil and Tadalafil.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/36133-premierzen-platinum-8000-recall-tainted-with-sildenafil-and-tadalafil. Based on FDA recall #D-0634-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0634-2021%22&limit=1).

The FDA announced on May 18, 2021, that Miracle 8989 is recalling PremierZEN Platinum 8000 capsules because they are tainted with Sildenafil and Tadalafil. The agency classified the Class I recall as voluntary.

How to tell if you have it

PremierZEN Platinum 8000 capsule
UPC 7 28175 42185 6
UPC 7 28175 42183 2

The hazard

The product was marketed without an approved New Drug Application or Abbreviated New Drug Application. The FDA found the capsules were tainted with Sildenafil and Tadalafil.

Context

GovInfoNow's records show other recent recalls of similar products include StuffbyNainax MR 7 SUPER 700000 Capsules (2025-12-15) and Shoolin Pharma Chem Sildenafil Recall (2026-08-03). SUN PHARMACEUTICAL Xyvona 3mg Tablets Recall occurred on 2026-05-22.

How to tell if you have this one

Look for PremierZEN Platinum 8000 capsules sold in a 1-count blister card (UPC 7 28175 42185 6) or packaged in boxes of 12 cards (UPC 7 28175 42183 2). The product is distributed by New Premier Group, Los Angeles, CA 90006. All lots remaining within expiry are included.

Brand
PremierZEN
Product
PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
USA Nationwide

Recall number	Product, codes & lots
D-0633-2021	PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006; All lots remaining within expiry.
D-0634-2021	PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006; All lots remaining within expiry.
D-0635-2021	maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028; All lots remaining within expiry.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

May 18, 2021Firm started the recall
Jun 22, 2021FDA classified it Class I
Jun 30, 2021Published in FDA’s Enforcement Report
Jul 12, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36133-premierzen-platinum-8000-recall-tainted-with-sildenafil-and-tadalafil">PremierZEN Platinum 8000 Recall: Tainted with Sildenafil and Tadalafil (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0634-2021 (May 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0634-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.