Boswellia herbal supplement recalled for unapproved drug claims and missing label
A New Life Herbs is recalling Boswellia herbal supplement due to unapproved drug claims on the label and a missing Supplement Facts label.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a product making unapproved drug claims about pain and inflammation treatment, constituting a risk-of-harm product. The missing Supplement Facts label compounds the risk by preventing consumers from understanding the product contents. No illnesses or injuries have been reported.
Plain-English summary
A New Life Herbs, LLC is recalling its Boswellia Herbal Supplement, a 1:5 alcohol double extract from frankincense marketed for pain and inflammation, due to labeling violations.
The product is being recalled for two reasons: it contains unapproved drug claims on its labeling, and it lacks the required Supplement Facts label, constituting misbranding under FDA regulations. These labeling deficiencies apply to all affected batches.
The recall affects 278 bottles distributed across 12 states: Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York, and Tennessee. Affected lot codes are T848B (EXP 11/30), T836B (EXP 10/30), T808B (EXP 9/30), T771B (EXP 7/30), T723B (EXP 3/30), T696B (EXP 1/29), T655B (EXP 10/29), T594B (EXP 4/29), and T536B (EXP 10/28).
Consumers who have purchased this product should stop using it and contact A New Life Herbs, LLC with questions or to arrange a return.
The recalled product
- Product
- Boswellia Herbal Supplement, 1:5 Alcohol Double Extract, Extracted from Frankincense with powerful anti-inflammatory properties, useful for pain & inflammation; packaged in a 2 oz. glass dropper bottle, UPC 284260392420
- Manufacturer
- A New Life Herbs, LLC
- Category
- Drug — Herbal Supplement
- Hazard
- unapproved-drug-claims
- mis-labeling
Distribution
Distributed in 12 states:
- AL
- AZ
- CA
- GA
- IL
- IN
- MN
- MO
- MS
- NC
- NY
- TN
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