Sundial Herbal Asthma Formula Recalled as Unapproved Drug
Sundial Herbal Products is recalling its Traditional Herbal Formula for Asthma because it is an unapproved drug with misbranded labeling.
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 status without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Sundial Herbal Products is recalling its "SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" product, which is packaged in boxes. The recall is required by an Order of Permanent Injunction.
The FDA has determined that the products are misbranded and are deemed unapproved drugs based on their labeling claims. The affected products were manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020.
The recall is limited to New York. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- "SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" 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 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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- CriticalBotanicalNow BodySlim Herbal Capsules Recalled for Undeclared Sibutramine
FDA (Drugs) · 2018-01-31
- ModerateHerbal Doctor Remedies Recalls Asthma Chest Rub for Misbranding
FDA (Drugs) · 2020-04-15
- ModerateHerbal Doctor Remedies Recalls Asma Stopper Capsules for Misbranding
FDA (Drugs) · 2020-04-15
- ModerateHerbal Doctor Remedies Recalls Asthma Balm Due to Manufacturing Deviations
FDA (Drugs) · 2019-08-14
- SevereHerbal dietary supplement recalled for undeclared drug ingredient
FDA (Drugs) · 2024-02-28
- CriticalFDA Recalls ZRECT for Women Herbal Supplement Due to Undeclared Drugs
FDA (Drugs) · 2017-07-19