Sundial Herbal Asthma Formula Recalled as Unapproved Drug
Sundial Herbal Products is recalling its Traditional Herbal Formula for Asthma because it is an unapproved drug with misbranded labeling.
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 and involves misbranding and unapproved drug status without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling its "SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" product, which is packaged in boxes. The recall is required by an Order of Permanent Injunction.
The FDA has determined that the products are misbranded and are deemed unapproved drugs based on their labeling claims. The affected products were manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020.
The recall is limited to New York. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- "SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" 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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