A New Life Herbs Baby Soothe recalled for unapproved drug claims
A New Life Herbs Baby Soothe herbal supplement is being recalled because it makes disease claims on the label without FDA approval and is missing required supplement facts information. The product was distributed in Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York, and Tennessee.
From the FDA notice · Read the official notice ↗
What to do
- Stop using Baby Soothe herbal supplement if you have it
- Do not give it to your baby
- Contact A New Life Herbs, LLC for instructions on how to return or dispose of the product
- Consult your pediatrician if your baby has used this product
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, water; packaged in a 2 oz. glass dropper bottle
- Sold in
- AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN
- Made for
- Infants
This recall covers 9 products — see all of them.
Details
- Units affected
- 49 bottles
- Illnesses reported
- None reported
- Manufactured in
- 17745 Us Highway 64, N/A, Somerville, TN, United States
- Classification
- Class II
- Recall number
- H-0342-2026
In the FDA's words
- Description
- Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, water; packaged in a 2 oz. glass dropper bottle Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label E164BS EXP 1/27 E128BS EXP 7/26 Distribution: AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN Affected quantity: 49 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… (this page)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 bottleH-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