Black Sage Herbs (Sundial) - Misbranded Drugs (2020)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK SAGE***1 oz.***USES: ALZHEIMER'S DISEASE, GINGIVITIS, MENOPAUSE, APPLY DIRECTLY TO SKIN FOR COLD SORES, ASTHMA***"; packaged in clear plastic zip-top bags
Brand
Sundial Herbal Products
Lot Codes / Batch Numbers
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Products Sold
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Sundial Herbal Products is recalling "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK SAGE***1 oz.***USES: ALZH due to Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY
Page updated: Jan 6, 2026