Baby Soothe herbal supplement recalled over unapproved drug claims and misbranding
A New Life Herbs is recalling 49 bottles of Baby Soothe Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
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: Scored 2 under the minor labeling criterion: the record cites unapproved claims and a missing Supplement Facts panel, with no stated illness or defect.
Plain-English summary
Baby Soothe Herbal Supplement, described on the label as promoting rest and helping ease colic, upset stomach and teething discomfort, containing catnip, chamomile, vegetable glycerin and water, in a 2 oz glass dropper bottle is being recalled by A New Life Herbs, LLC.
The reason given in the enforcement record is unapproved drug claims on the product labeling, and that the product is misbranded due to having no Supplement Facts label.
The recall covers 49 bottles, codes E164BS, expiry 1/27, and E128BS, expiry 7/26. Distribution covered Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York and Tennessee. The FDA has classified the action as Class II.
The record cites labeling and misbranding issues rather than a contamination or defect, and states no illnesses. Consumers should follow the firm's instructions.
The recalled product
- Product
- Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, water; packaged in a 2 oz. glass dropper bottle
- Manufacturer
- A New Life Herbs, LLC
- Category
- Food — Herbal supplement
- Hazard
- unapproved-claims
- misbranding
- 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)
- E164BS EXP 1/27 E128BS EXP 7/26
Distribution
Distributed in 12 states:
- AL
- AZ
- CA
- GA
- IL
- IN
- MN
- MO
- MS
- NC
- NY
- TN
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