Why it was recalled
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Product description
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***"
Lot numbers, UPCs & expiration codes
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Where it was sold
NY
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1487-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 30, 2020
- FDA report date
- Sep 9, 2020
- Quantity
- Unknown
- Recall type
- FDA Mandated
- Recalling firm
- Sundial Herbal Products
Original FDA data
Every field from FDA enforcement report F-1487-2020, exactly as published.
Show all FDA fields
- City
- Bronx
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 85882
- Address
- 3609 Boston Rd
- Code information
- Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
- Postal code
- 10466-5810
- Report date
- Sep 9, 2020
- Product type
- Food
- Recall number
- F-1487-2020
- Classification
- Class II
- Recalling firm
- Sundial Herbal Products
- Product quantity
- Unknown
- Termination date
- Oct 26, 2022
- Reason for recall
- Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- Voluntary / mandated
- FDA Mandated
- Product description
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***"
- Distribution pattern
- NY
- Recall initiation date
- Jun 30, 2020
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2020