Sundial Herbal Products

Recall #F-1444-2020 · Initiated 2020-06-30

Plain-language summary

by FoodRecallsDB.info

What happened

Sundial Herbal Products is recalling an Ethiopian Flax Seed Oil & Honey Blend product because the company made medical claims on the label (like curing bladder and kidney problems) without FDA approval. The product is being treated as an unapproved drug rather than a dietary supplement because of these claims.

Who is at risk

Anyone who purchased this product in New York should be aware of this recall.

What to do

Stop using the product and do not consume it. Contact Sundial Herbal Products or your retailer about how to return or dispose of the product safely.

Product

ETHIOPIAN FLAX SEED OIL & HONEY BLEND; "***clears bladder, kidney, urinary tract prostate womb and colon, sooths stomach, lowers cholesterol and blood pressure***DIST. BY: SUNDIAL HERBAL PRODUCTS***"

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