Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in
Summary
The FDA issued a Class II for Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving by A New Life Herbs, LLC. Reason: Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label.
Details
Source
Food Recall
External ID
H-0345-2026
Action Date
2025-12-31
Status
Ongoing
Category
food
Product Description
Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic dropper bottle
Lot/Code Info: T553MF EXP 12/28
Quantity Affected: 22 bottles
Reason for Recall
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Distribution
AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-20
Company
Somerville, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 33 food recalls issued in the same week, part of 204 food-related FDA actions this month.
A New Life Herbs, LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (A New Life Herbs, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does A New Life Herbs, LLC have FDA actions?
A New Life Herbs, LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0345-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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