Sundial Bay Leaves Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling bay leaves labeled with unapproved drug claims. The FDA determined the products are misbranded and unapproved drugs.
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 corresponds to a moderate severity score. The hazard involves misbranding and unapproved drug claims rather than a physical defect or reported illness.
Plain-English summary
Sundial Herbal Products is recalling its 1-ounce bags of Traditional Organic Herbs Bay Leaves. The recall is required by an Order of Permanent Injunction. The products were distributed in New York and were manufactured, processed, packed, held, or distributed between January 1, 2014, and May 27, 2020.
The FDA determined that the products are misbranded and deemed unapproved drugs based on their labeling. The packaging lists uses for cough, cold, diabetes, aches, pains, digestion, fever, and flu symptoms, which constitute drug claims for a product that is not approved as a drug.
Consumers who purchased these products should stop using them. The recall is a regulatory action to address the misbranding and unapproved drug status of the herbal product.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BAY LEAVES***1 oz.***USES: COUGH, COLD, DIABETES, ACHES, PAINS, DIGESTION, FEVER, FLU SYMPTOMS***"; 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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