Sundial African Manback Tonic Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Sundial Traditional African Manback Tonic 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 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, which typically corresponds to a moderate severity level. The source text does not report any illnesses or injuries, and the primary issue is regulatory (misbranding/unapproved drug status) rather than a specific physical hazard like contamination.
Plain-English summary
Sundial Herbal Products is recalling Sundial Traditional African Manback Tonic, which is packaged in glass bottles. The recall is being conducted under an Order of Permanent Injunction. The product was manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020.
The FDA has determined that the products are misbranded and deemed unapproved drugs based on the claims made in their labeling. The recall is limited to products distributed in New York (NY).
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- "SUNDIAL***TRADITIONAL AFRICAN MANBACK TONIC***remember the strength of the reproductive organ, reflects the strength of the entire body. Take SUNDIAL AFRICAN MANBACK TONIC to strengthen, rejuvenate & energize***" packaged in glass bottles
- 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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