Mullein ear drops recalled over unapproved drug claims and missing supplement facts
A New Life Herbs is recalling 22 bottles of Ear Drops 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
Ear Drops Herbal Supplement, a mullein flower alcohol tincture 1:5 in a 0.5 oz plastic dropper bottle, labelled with pain relieving and antibiotic properties, 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 22 bottles coded T553MF with an expiry of 12/28. 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
- Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic 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)
- T553MF EXP 12/28
Distribution
Distributed in 12 states:
- AL
- AZ
- CA
- GA
- IL
- IN
- MN
- MO
- MS
- NC
- NY
- TN
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