The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·H-0172-2027·Announced 2026-10-28

Primal Herbs Volume Recalled for Unlabeled Sildenafil

Primal Supplements Group LLC is recalling Primal Herbs Volume herbal supplement because FDA analysis confirmed it contains sildenafil, which is not listed on the label.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source identifies the hazard as the presence of sildenafil, an unlisted pharmaceutical ingredient, in a dietary supplement. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Primal Supplements Group LLC is recalling Primal Herbs, Volume, Herbal Supplement, Net Wt. 8.5 oz, 30 servings. The recall was initiated after FDA laboratory analysis confirmed that the product contains sildenafil, a substance not listed on the product label.

The affected product was sold on the website primalherbs.com. The recall covers all orders placed between July 2, 2025, and September 19, 2025, on that website.

Consumers who purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.

The recalled product

Product
PRIMAL HERBS, VOLUME, HERBAL SUPPLEMENT, Net Wt. 8.5 oz, 30 servings

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • All orders placed between July 2
  • 2025
  • and September 19
  • on the website: primalherbs.com

Distribution

Distribution scope not specified by the agency.

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