Elevated risk U.S. Food and Drug Administration

Primal Herbs Dietary supplement recall: Product contains sildenafil

Recall published 8 months ago

Product contains sildenafil

Primal Herbs Dietary supplements — recalled dietary supplements
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

What the notice says: We apologise for the inconvenience and concern this recall may cause our customers.

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 27, 2026
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Primal Herbs
Product type
Dietary supplements

Products covered by this recall

Dietary supplement

What the company announced

This recall is being conducted in coordination with the U.S. Food and Drug Administration (FDA).

Here is a link to our voluntary recall: ( link to the FDA recall article will be presented here )

FOR IMMEDIATE RELEASE - February 27 2026 — Albuquerque, New Mexico, Primal Supplements Group LLC is voluntarily recalling all orders of Primal Herbs Volume placed between July 2 and September 19, 2025, because FDA laboratory analysis confirmed that Primal Herbs Volume contains sildenafil not listed on the product label.

Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. FDA approval of Viagra is restricted to use under the supervision of a licensed health care professional. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Customers who placed an order between July 2, 2025 and September 19, 2025, on the website: primalherbs.com , should discontinue use immediately. The product is packaged in 8.5 oz round containers with green labels.

If your order was placed during this timeframe, please stop using the product and contact our team at [email protected] with your order number. We'll take care of you right away with your choice of a complimentary replacement shipment or full store credit, along with simple return instructions.

Updates will be posted here as needed.

For questions or concerns, please contact [email protected] or +1 (856) 420-6117. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Primal Herbs is conducting this recall voluntarily and takes this matter very seriously. We apologise for the inconvenience and concern this recall may cause our customers. Our company is committed to ensuring the quality of our products and the well-being of our consumers.

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

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 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

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

  • 8.5 oz

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

Primal Herbs — This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: We'll take care of you right away with your choice of a complimentary replacement shipment or full store credit, along with simple return instructions.

Company contact: Primal Supplements Group LLC — Consumers: 1 (856) 420-6117, [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 Primal Herbs dietary supplements recalled?

Product contains sildenafil We apologise for the inconvenience and concern this recall may cause our customers.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

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?

The notice says: We'll take care of you right away with your choice of a complimentary replacement shipment or full store credit, along with simple return instructions.

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