Sundial Herbal Products Recalls Ethiopian Flax Seed Oil and Honey Blend
Sundial Herbal Products is recalling Ethiopian Flax Seed Oil & Honey Blend because it is misbranded and deemed an unapproved drug.
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, which typically involves a temporary or medically reversible adverse health consequence. The source text identifies the hazard as misbranding and unapproved drug status based on labeling claims, without reporting specific injuries or illnesses, aligning with the Moderate severity criteria for labeling errors and regulatory violations.
Plain-English summary
Sundial Herbal Products is recalling its Ethiopian Flax Seed Oil & Honey Blend. The recall is required by an Order of Permanent Injunction. The product was distributed in New York.
The FDA determined that the products are misbranded and deemed unapproved drugs based on labeling claims. The label includes claims that the product clears the bladder, kidney, urinary tract, prostate, womb, and colon, soothes the stomach, and lowers cholesterol and blood pressure.
The recall covers product manufactured, processed, packed, held, and/or distributed during the time period beginning January 1, 2014, through May 27, 2020. Consumers should stop using the product and contact Sundial Herbal Products for further instructions.
The recalled product
- Product
- ETHIOPIAN FLAX SEED OIL & HONEY BLEND; "***clears bladder, kidney, urinary tract prostate womb and colon, sooths stomach, lowers cholesterol and blood pressure***DIST. BY: SUNDIAL HERBAL PRODUCTS***"
- Manufacturer
- Sundial Herbal Products
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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