Sundial Blood Leaf Herbal Product Recalled as Unapproved Drug
Sundial Herbal Products is recalling Blood Leaf herbal products because they are misbranded and deemed unapproved drugs based on labeling 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 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant regulatory enforcement (Permanent Injunction) or structural defects warrant a score of 4 (Severe).
Plain-English summary
Sundial Herbal Products is recalling its "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLOOD LEAF***1oz.***USES: SUPPLIES IRON, FOOD SUPPLEMENT***ANEMIA***" product. The product is packaged in clear plastic zip-top bags. This recall was 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 affected products were manufactured, processed, packed, held, and/or distributed during the time period beginning January 1, 2014, through May 27, 2020.
Distribution was limited to New York. Consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLOOD LEAF***1oz.***USES: SUPPLIES IRON, FOOD SUPPLEMENT***ANEMIA***"; packaged in clear plastic zip-top bags
- Manufacturer
- Sundial Herbal Products
- Category
- Food — Herbal Supplements
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.
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