Sundial Mahogany Bark Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Mahogany Bark herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
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 illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling SUNDIAL Traditional Herbal Products Mahogany Bark, 2 oz., packaged in zip-top plastic bags. The recall is required by an Order of Permanent Injunction.
The FDA has determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The product labels include uses for body weaknesses, male reproductive organs, and infertility.
The affected products were 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 should stop using the product and follow instructions from the recalling firm or the FDA.
The recalled product
- Product
- SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — Herbal 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
Same manufacturer · Sundial Herbal Products
See all →- ModerateSundial Marsh Marigold Herbal Product Recalled for Misbranding
FDA (Food) · 2020-09-09
- ModerateSundial Herbal Blood Pressure Formula Recalled for Misbranding and Unapproved Drug Status
FDA (Food) · 2020-09-09
- ModerateSundial Cinnamon Herbal Product Recalled for Misbranding and Unapproved Drug Claims
FDA (Food) · 2020-09-09
- ModerateSundial Bread Nut Herbal Product Recalled for Unapproved Drug Claims
FDA (Food) · 2020-09-09
- ModerateSundial White Sage Herbal Product Recalled for Misbranding and Unapproved Drug Claims
FDA (Food) · 2020-09-09
Same hazard · mis labeling
See all →- High
- ModerateRecall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- SevereVegetal Vigra Capsules Recalled for Containing Unapproved Sildenafil
FDA (Drugs) · 2023-09-06
- CriticalBotanicalNow BodySlim Herbal Capsules Recalled for Undeclared Sibutramine
FDA (Drugs) · 2018-01-31
- ModerateIowa Select Herbs Recalls Magnolia Bark for Misbranding and Adulteration
FDA (Food) · 2016-05-11
- CriticalFDA Recalls ZRECT for Women Herbal Supplement Due to Undeclared Drugs
FDA (Drugs) · 2017-07-19
- ModerateIowa Select Herbs Recalls Yohimbe Bark for Misbranding and Adulteration
FDA (Food) · 2016-05-11
- SevereUnapproved herbal capsules containing sildenafil recalled by FDA
FDA (Drugs) · 2018-02-07