Elevated risk U.S. Food and Drug Administration

PrimeZEN Black 6000 male enhancement capsules recall: Product contains undeclared tadalafil and sildenafil

Recall published 3+ years ago

Product contains undeclared tadalafil and sildenafil

PrimeZEN Prescription & OTC drugs — recalled prescription & otc drugsPrimeZEN Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: Risk Statement: PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
February 13, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
PrimeZEN
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
728175521891

Products covered by this recall

PrimeZEN Black 6000 male enhancement capsules

What the company announced

FOR IMMEDIATE RELEASE – 2/13/2023 – Pomona, California, Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil & tadalafil. Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil, tadalafil in PrimeZen Black 6000 capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products. Volt Candy has not received reports of state adverse events or injuries to date.

Product was distributed Nationwide to consumers online at the website [email protected]. PrimeZen Black 6000 is marketed as a dietary supplement for male enhancement and is packaged in a blister card with one capsule, UPC code: 728175521891. The affected PrimeZen Black 6000 includes the following lot number [NPINPB 1003] with an expiration date of 08/16/2025. The product can be identified by the card color in black with the name on it PrimeZen Black 6000. See picture of product below.

Volt Candy is notifying their online customers by email and is arranging for return of all recalled products. Consumers or those with product in their possession should stop using and return the affected product PrimeZen Black 6000, lot number [NPINPB 1003] Expiration date 08/16/2025 to this address:

Volt Candy

324 S. Diamond Bar Blvd

#212

Diamond Bar, CA 91765

Consumers with questions regarding this recall can contact Volt Candy by e-mail [email protected] on weekdays between 9am-5pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 728175521891

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2000

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 08/16/2025

Package size

Match the net weight or the piece count on the front of the pack.

  • 2000 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

PrimeZEN — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Report any reaction to the FDA so it is recorded against this recall.
  3. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  4. If someone does avoid it, stop serving it and check anything already cooked with it.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Volt Candy — Consumers: Volt Candy, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was PrimeZEN prescription & otc drugs recalled?

Product contains undeclared tadalafil and sildenafil Risk Statement: PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 728175521891; lot code 2000; best-by date 08/16/2025. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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