Sundial Herbal Formula Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling its Traditional Herbal Formula for Flu-Allergies HayFever because the product is misbranded and deemed 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 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 its "SUNDIAL***TRADITIONAL HERBAL FORMULA***Flu-Allergies HayFever***" product, which is packaged in boxes. The recall is being conducted under an Order of Permanent Injunction issued by the U.S. Food and Drug Administration.
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 affected products were 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***Flu-Allergies HayFever***" 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.
See all 68 products in this recall →Related recalls
Same manufacturer · Sundial Herbal Products
See all →- 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
- ModerateSundial Mahogany Bark Herbal Product Recalled for 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
- SevereUnapproved herbal capsules containing sildenafil recalled by FDA
FDA (Drugs) · 2018-02-07
- CriticalFDA Recalls ZRECT for Women Herbal Supplement Due to Undeclared Drugs
FDA (Drugs) · 2017-07-19
- CriticalBotanicalNow BodySlim Herbal Capsules Recalled for Undeclared Sibutramine
FDA (Drugs) · 2018-01-31
- CriticalCaverFlo Natural Herbal Coffee Recalled for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2017-08-30
- SevereHerbal dietary supplement recalled for undeclared drug ingredient
FDA (Drugs) · 2024-02-28
- ModerateIowa Select Herbs Recalls Hibiscus Flowers for Misbranding and Adulteration
FDA (Food) · 2016-05-11