CLASS II Food recall · Reported 31 Dec 2025 · FDA Enforcement Report
Ear Drops Herbal Supplement recalled by A New Life Herbs
A New Life Herbs is recalling Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and, distributed in 12 states. The recall was initiated on 20 Nov 2025 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- H-0345-2026
- FDA event ID
- 98037
- Recalling firm
- A New Life Herbs, Somerville, TN
- Brand
- Ear Drops
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2025
- FDA classified
- 23 Dec 2025
- Reported
- 31 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Product category
- Herbal Supplements
Timeline
| 20 Nov 2025 | Recall initiated by company | |
| 23 Dec 2025 | Classified by FDA | +33 days |
| 31 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Product as listed by the FDA
Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic dropper bottle
Where it was distributed
AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN
AlabamaArizonaCaliforniaGeorgiaIllinoisIndianaMinnesotaMissouriMississippiNorth CarolinaNew YorkTennessee
Questions about this recall
Is Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and recalled?
Yes. A New Life Herbs recalled Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and on 20 Nov 2025. The recall is Class II and its status is Terminated. Recall number H-0345-2026.
Why was it recalled?
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Which lots are affected?
T553MF EXP 12/28
Where was it sold?
AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from A New Life Herbs
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Baby Allergy Herbal Supplement, Contains recalled by A New Life Herbs | A New Life Herbs | Labeling Errors | 12 states |
| Food | CLASS II | Baby Soothe Herbal Supplement, Promotes rest recalled | A New Life Herbs | E. coli | 12 states |
| Food | CLASS II | Boswellia Herbal Supplement, 1:5 Alcohol Double Extract recalledBoswellia | A New Life Herbs | Labeling Errors | 12 states |
| Food | CLASS II | Pain Away Herbal Supplement recalled by A New Life HerbsPain Away | A New Life Herbs | Labeling Errors | 12 states |
| Food | CLASS II | Anti-virus Herbal Supplement, 1:5 Alcohol Tincture recalledAnti-virus | A New Life Herbs | Labeling Errors | 12 states |
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| Food | ANNOUNCED | Moringa Leaf Powder recalled by Foods AliveFoods Alive | Foods Alive | Salmonella | Nationwide |
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| Food | CLASS II | A-P Herbal Supplement May Contain Nuts recalled by Byron White FormulasByron | Byron White Formulas | Undeclared Tree Nuts | 50 states |
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