The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-1462-2020·Announced 2020-09-09

Sundial Black Sage Herbal Product Recalled for Unapproved Drug Claims

Sundial Herbal Products is recalling Black Sage herbal products under a permanent injunction because the labeling makes unapproved drug claims.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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, which aligns with the rubric for moderate severity labeling issues.

Plain-English summary

Sundial Herbal Products is recalling Sundial Traditional Organic Herbs Black Sage, packaged in clear plastic zip-top bags. The recall is required by an Order of Permanent Injunction.

The FDA determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The product labeling lists uses for Alzheimer's disease, gingivitis, menopause, cold sores, and asthma.

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 follow instructions from the recalling firm or the FDA.

The recalled product

Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK SAGE***1 oz.***USES: ALZHEIMER'S DISEASE, GINGIVITIS, MENOPAUSE, APPLY DIRECTLY TO SKIN FOR COLD SORES, ASTHMA***"; packaged in clear plastic zip-top bags
Manufacturer
Sundial Herbal Products
Category
Food — Herbal Supplements
Hazard

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 →

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