A New Life Herbs mullein ear drops recalled for unapproved drug claims
A New Life Herbs is recalling its Mullein flower alcohol tincture ear drops because the product makes unapproved claims about treating pain and infection, and the bottle lacks required supplement labeling. The FDA found 22 bottles (lot T553MF, expiring 12/28) distributed across multiple states.
From the FDA notice · Read the official notice ↗
What to do
- Stop using this product immediately if you have it
- Do not use it in ears or take it internally
- Dispose of the bottle safely
- Contact A New Life Herbs or your retailer if you have questions
Is yours affected?
Compare your label or packaging with 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
- Sold in
- AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN
- Made for
- Adults
This recall covers 9 products — see all of them.
Details
- Units affected
- 22 bottles
- Illnesses reported
- None reported
- Manufactured in
- 17745 Us Highway 64, N/A, Somerville, TN, United States
- Classification
- Class II
- Recall number
- H-0345-2026
In the FDA's words
- 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 Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label T553MF EXP 12/28 Distribution: AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN Affected quantity: 22 bottles
- Hazard
- Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
9 products in this recall
A New Life Herbs supplements recalled for unapproved drug claims
A New Life Herbs is recalling nine herbal supplement products sold as alcohol tincture, capsule, and dropper-bottle products, including products for immune, pain, sinus, and baby-care use. The FDA says the labels make unapproved drug claims and the products lack a Supplement Facts label. The products were distributed in AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, and TN, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Anti-virus Herbal Supplement, 1:5 Alcohol Tincture, Helps to stop viral replication, expectorant properties, Contains: Forsethia blossoms, Sumac berries, Pin…H-0340-2026 · 116 bottles
- Baby Allergy Herbal Supplement, Contains: Echinacea Purpurea, Oregon Grape Root, Dandelion & Burdock Root, Fenugreek, Ginger Root in vegetable glycerin; pack…H-0341-2026 · 23 bottles
- Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, wate…H-0342-2026 · 49 bottles
- Boswellia Herbal Supplement, 1:5 Alcohol Double Extract, Extracted from Frankincense with powerful anti-inflammatory properties, useful for pain & inflammati…H-0343-2026 · 278 bottles
- Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properties; packaged in a 2 oz. glass dropper…H-0344-2026 · 144 bottles
- Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic dropper bottle (this page)H-0345-2026 · 22 bottles
- Organic Ginger Root Herbal Supplement, Natural anti-inflammatory properties, supports gut, increases circulation, 50 capsules/560 mg, packaged in a plastic bagH-0346-2026 · 48 bags
- Pain Away Herbal Supplement, Analgesic & anti-inflammatory properties, Wood Betony & White Willow in vegetable glycerin, packaged in a 4.5 oz. glass bottle o…H-0347-2026 · 275 bottles
- Sinus Cap Herbal Supplement, Herbs containing antibiotic, drying, expectorant, and emollient properties, Fenugreek, Thyme, Oregon Grape Root, & Bentonite Cla…H-0348-2026 · 38 bags