Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properti
Summary
The FDA issued a Class II for Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy by A New Life Herbs, LLC. Reason: Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label.
Details
Source
Food Recall
External ID
H-0344-2026
Action Date
2025-12-31
Status
Ongoing
Category
food
Product Description
Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properties; packaged in a 2 oz. glass dropper bottle, UPC 284588087831
Lot/Code Info: T720CH EXP 3/30 T656CH EXP 10/29 T618CH EXP 7/29 T568CH EXP 1/29 T532CH EXP 10/28
Quantity Affected: 144 bottles
Reason for Recall
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Distribution
AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-20
Company
Somerville, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 33 food recalls issued in the same week, part of 204 food-related FDA actions this month.
A New Life Herbs, LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (A New Life Herbs, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does A New Life Herbs, LLC have FDA actions?
A New Life Herbs, LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0344-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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