The Recall Desk
ModerateFDA (Food)·F-1448-2020·Announced 2020-09-09

Sundial Herbal Products Recalls Mitmitta Cayenne Pepper Product

Sundial Herbal Products is recalling Mitmitta (Cayenne Pepper) because it is misbranded and deemed an unapproved drug due to labeling claims.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves misbranding and unapproved drug claims without reported illnesses or injuries, fitting the criteria for moderate severity.

Plain-English summary

Sundial Herbal Products is recalling Mitmitta (Cayenne Pepper) under a permanent injunction order. The product is misbranded and deemed an unapproved drug based on its labeling claims, which state that it prevents heart attacks, lowers high blood pressure, stops internal bleeding, heals ulcers, improves circulation, and thins blood.

The recall covers products manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020. The distribution pattern is listed as New York (NY).

Consumers should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
Mitmitta (Cayenne Pepper); "Traditional Uses: Prevents heart attacks, and lowers high blood pressure, stops internal bleeding, Heals ulcers and pains there of: Improves circulation, thins blood and keeps it moving***"

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 (5)

  • Product manufactured
  • processed
  • packed
  • held
  • and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 68 recalled by Sundial Herbal Products under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 68 products in this recall →