Baby Allergy Herbal Supplement Recalled for Unapproved Drug Claims and Misbranding
A New Life Herbs' Baby Allergy Herbal Supplement is recalled due to unapproved drug claims on the labeling and absence of a required Supplement Facts label. The recall affects 23 bottles distributed across 12 states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall addresses labeling and regulatory compliance issues, not a documented product safety hazard. No illnesses or injuries have been reported, and the violations involve unapproved drug claims and missing required supplement labeling.
Plain-English summary
A New Life Herbs, LLC is recalling its Baby Allergy Herbal Supplement due to unapproved drug claims on the product labeling and the absence of a required Supplement Facts label. The product is a 2 oz. glass dropper bottle containing echinacea purpurea, Oregon grape root, dandelion and burdock root, fenugreek, and ginger root in vegetable glycerin.
The product is misbranded and in violation of FDA regulations because it bears unapproved drug claims and lacks the required Supplement Facts label mandated for dietary supplements. The specific regulatory violations concern how the product is labeled and the claims made on the labeling.
The recall affects approximately 23 bottles with code E166SA EXP 4/28 that were distributed to consumers in Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York, and Tennessee.
Consumers who have purchased this product are advised to discontinue use and discard it. Those with questions should contact A New Life Herbs, LLC.
The recalled product
- Product
- Baby Allergy Herbal Supplement, Contains: Echinacea Purpurea, Oregon Grape Root, Dandelion & Burdock Root, Fenugreek, Ginger Root in vegetable glycerin; packaged in a 2 oz. glass dropper bottle, UPC 249953949282
- Manufacturer
- A New Life Herbs, LLC
- Category
- Food — Dietary Supplement
- Hazard
- unapproved-drug-claims
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- E166SA EXP 4/28
Distribution
Distributed in 12 states:
- AL
- AZ
- CA
- GA
- IL
- IN
- MN
- MO
- MS
- NC
- NY
- TN
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