Sundial Herbal Arthritis Formula Recalled for Misbranding and Unapproved Drug Status
Sundial Herbal Products is recalling its Traditional Herbal Formula for Arthritis because the product is misbranded and considered an unapproved drug.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the product is deemed an unapproved drug.
Plain-English summary
Sundial Herbal Products is recalling its "SUNDIAL***TRADITIONAL HERBAL FORMULA***ARTHRITIS***" product, which is packaged in boxes. The recall is being conducted under an Order of Permanent Injunction.
The FDA has determined that the product is misbranded and is deemed an unapproved drug based on the claims made on its labeling. The agency classifies this recall as Class II.
The product was manufactured, processed, packed, held, and/or distributed between January 1, 2014, and 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 FORMULA***ARTHRITIS***" 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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