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Primal Herbs Recalls Volume Due to Undeclared Sildenafil

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Filed February 27th, 2026
Detected March 12th, 2026
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Summary

Primal Supplements Group LLC is voluntarily recalling all orders of Primal Herbs Volume due to the undeclared presence of sildenafil, an active ingredient in Viagra. The FDA confirmed the undeclared ingredient, which poses a risk of dangerous blood pressure drops when interacting with nitrates.

What changed

Primal Supplements Group LLC, in coordination with the FDA, is voluntarily recalling all Primal Herbs Volume products sold between July 2 and September 19, 2025. FDA laboratory analysis confirmed the presence of sildenafil, the active ingredient in Viagra, which was not declared on the product label. Sildenafil is a prescription drug used to treat erectile dysfunction and its undeclared presence in a dietary supplement poses a significant health risk, particularly for individuals with pre-existing conditions who may be taking nitrate medications, as it can cause dangerous drops in blood pressure.

Consumers who purchased Primal Herbs Volume during the specified timeframe are instructed to immediately discontinue use of the product. They should contact Primal Supplements Group LLC via email or phone to arrange for a complimentary replacement shipment or full store credit, along with return instructions. Consumers experiencing any adverse effects should consult a healthcare provider and report the incident to the FDA's MedWatch program. This recall highlights the importance of accurate ingredient labeling for dietary supplements and the potential dangers of unlisted active pharmaceutical ingredients.

What to do next

  1. Discontinue use of Primal Herbs Volume if purchased between July 2 and September 19, 2025.
  2. Contact Primal Supplements Group LLC for a replacement or store credit.
  3. Consult a healthcare provider if any adverse effects are experienced.

Source document (simplified)

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Summary

Company Announcement Date:

February 27, 2026

FDA Publish Date:

March 11, 2026

Product Type: Dietary Supplements
Food & Beverages Reason for Announcement: Recall Reason Description Product contains sildenafil Company Name: Primal Supplements Group LLC Brand Name: Brand Name(s) Primal Herbs Product Description: Product Description Dietary supplement

Company Announcement

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 hello@primalherbs.com 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 hello@primalherbs.com 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.

Company Contact Information

Consumers: 1 (856) 420-6117 hello@primalherbs.com

Product Photos

  • Content current as of:

03/11/2026

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
Food and Drug Administration
Filed
February 27th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Consumers Food manufacturers
Geographic scope
Nationwide (US)

Taxonomy

Primary area
Food Safety
Operational domain
Compliance
Topics
Dietary Supplements Drug Interactions

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