Sundial Herbal Blood Pressure Formula Recalled for Misbranding and Unapproved Drug Status
Sundial Herbal Products is recalling Sundial Traditional Herbal Formula Blood Pressure boxes under a permanent injunction. The products are misbranded and deemed unapproved drugs due to 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 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 status without reported illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling Sundial Traditional Herbal Formula Blood Pressure, packaged in boxes, pursuant to an Order of Permanent Injunction. The recall is required because the products are misbranded and deemed unapproved drugs based on their labeling claims.
The recall covers products manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020. Distribution was limited to New York. The source text does not specify the total quantity of units recalled or report any illnesses or injuries associated with the product.
Consumers should stop using the product and follow instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- "SUNDIAL***TRADITIONAL HERBAL FORMULA***BLOOD PRESSURE***" packaged in boxes
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — Herbal Supplement
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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