Sundial Herbal Products Recalls Ethiopian Coffee for Unapproved Drug Claims
Sundial Herbal Products is recalling Ethiopian Coffee under a permanent injunction because the product is misbranded and deemed an unapproved drug based on its 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 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 agency classification is FDA Class II, and the source explicitly states the products are 'deemed unapproved drugs,' which aligns with the rubric criteria for Severe severity involving significant regulatory violations and potential health risks.
Plain-English summary
Sundial Herbal Products is recalling Ethiopian Coffee under a 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. The distribution pattern is listed as New York (NY).
Consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Ethiopian Coffee
- Manufacturer
- Sundial Herbal Products
- Category
- Food — Beverage
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.
See all 68 products in this recall →Related recalls
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