Herbal Ear Drops Supplement Recalled for Unapproved Drug Claims
A New Life Herbs is recalling 22 bottles of Mullein flower alcohol tincture ear drops for making unapproved drug claims and lacking required Supplement Facts labeling.
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 involves regulatory labeling violations (unapproved drug claims and missing Supplement Facts label). Without reported illnesses, injuries, or contamination, the hazard is regulatory non-compliance rather than a direct product safety threat, fitting the Moderate category for labeling errors.
Plain-English summary
A New Life Herbs, LLC is recalling its Ear Drops Herbal Supplement, a Mullein flower alcohol tincture 1:5 product marketed with pain relieving and antibiotic properties, due to unapproved drug claims and missing Supplement Facts labeling. The product was distributed in Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York, and Tennessee. The recalled product is identified by the code T553MF EXP 12/28 and contains 22 bottles.
The FDA has determined that the product is misbranded because it makes therapeutic claims (pain relieving and antibiotic properties) without FDA approval for a dietary supplement. Additionally, the product lacks the required Supplement Facts label, which is mandatory for dietary supplement products.
Consumers who have purchased this product should discontinue use.
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
- Drug — 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)
- T553MF EXP 12/28
Distribution
Distributed in 12 states:
- AL
- AZ
- CA
- GA
- IL
- IN
- MN
- MO
- MS
- NC
- NY
- TN
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27