Sundial Hemp Seed Oil Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Sundial Hemp Seed Oil 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 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 Hemp Seed Oil under a permanent injunction order. The U.S. Food and Drug Administration has determined that the product is misbranded and is deemed an unapproved drug due to specific claims made on its labeling.
The recall covers products manufactured, processed, packed, held, or distributed between January 1, 2014, and May 27, 2020. Distribution was limited to New York. The agency has classified this recall as Class II.
Consumers who have purchased this product should stop using it and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- "SUNDIAL***Hemp Seed Oil***"
- 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
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 →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
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
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateHerbal Doctor Remedies Recalls Sweat Oil for Unapproved New Drug Status
FDA (Drugs) · 2020-04-15
- ModerateIowa Select Herbs Fennel Seed Recalled for Misbranding and Adulteration
FDA (Food) · 2016-05-11
- ModerateIowa Select Herbs Recalls Jewel Weed for Misbranding and Adulteration
FDA (Food) · 2016-05-11
- LowIowa Select Herbs Recalls Psoralea Seed for Misbranding and Adulteration
FDA (Food) · 2016-05-11
- LowIowa Select Herbs Recalls Solomon Seal Supplements for Misbranding
FDA (Food) · 2016-05-11
- ModerateIowa Select Herbs Recalls Grape Seed Leaf for Misbranding and Adulteration
FDA (Food) · 2016-05-11