Sundial Herbal Products

Recall #F-1473-2020 · Initiated 2020-06-30

Plain-language summary

by FoodRecallsDB.info

What happened

Sundial Herbal Products is recalling pimento herb products sold in New York because the company made health claims on the label (such as treating diabetes, preventing strokes, or reducing tobacco urges) without FDA approval. These types of claims turn the product into an unapproved medication, which is not allowed.

Who is at risk

Anyone who purchased this product should be aware of the recall, though the main concern is that the health claims on the label are unproven rather than a safety hazard from contamination.

What to do

If you have this product, stop using it and dispose of it safely. Contact Sundial Herbal Products or your local health department if you have questions, or speak with your doctor if you've been using it to treat a health condition.

Product

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PIMENTO***1 oz.***USES: STIMULANT, DIABETES, WORMS, PREVENTS STROKES, REDUCES TOBACCO URGE, WARMS BODY***"; packaged in clear plastic zip-top bags

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Quantity affected

Unknown

Distribution

Lot / code info

Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated