Home / Sundial Herbal Products / F-1460-2020
Class II
Sundial Herbal Products
Recall #F-1460-2020 · Initiated 2020-06-30
Plain-language summary
by FoodRecallsDB.infoWhat happened
Sundial Herbal Products' sea moss/Irish moss product sold in 2oz bags has been recalled because the company made health claims on the label (such as treating ulcers, thyroid problems, and detoxification) without FDA approval. The product is considered misbranded and an unapproved drug under FDA regulations.
Who is at risk
Anyone who purchased this product should be aware of the recall, though no illness or injury has been reported.
What to do
If you purchased this Sundial sea moss product in a clear plastic zip-top bag, stop using it and dispose of it safely. Contact Sundial Herbal Products or your retailer if you have questions about your purchase.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERB***SEA MOSS/IRISH MOSS***2oz.***USES: IODINE, BREAKS UP FAT & MUCOUS, ADD, ULCERS, CALCIUM, THYROID, DETOX***"; 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
NY
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
2022-10-26
Recalling firm
Sundial Herbal Products
3609 Boston Rd
Bronx, NY 10466-5810
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.
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