Sundial Herbal Products Recalls Cocoa Balls for Unapproved Drug Claims
Sundial Herbal Products is recalling Sundial Cocoa Balls because the product is misbranded and deemed an unapproved drug based on 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 2/5 (Moderate).
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 claims without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling "SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags. The recall is required by an Order of Permanent Injunction. The product is considered misbranded and is deemed an unapproved drug based on its labeling claims.
The recall covers products manufactured, processed, packed, held, and/or distributed during the time period beginning January 1, 2014, through May 27, 2020. The distribution pattern is listed as New York (NY).
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- "SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
- Manufacturer
- Sundial Herbal Products
- Category
- Food — 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.
See all 68 products in this recall →Related recalls
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