Moderate riskFDA FoodClass II

A New Life Herbs baby supplement recalled for unapproved drug claims

A New Life Herbs is recalling its Baby Allergy Herbal Supplement because the product makes drug claims on the label that are not approved by the FDA, and it is missing required Supplement Facts labeling. The product contains echinacea, Oregon grape root, dandelion, burdock root, fenugreek, and ginger root in vegetable glycerin, sold in a 2 oz. glass dropper bottle.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using the product immediately if you have it
  2. Do not give it to your child
  3. Contact A New Life Herbs or your retailer for a refund or disposal instructions
  4. Call your pediatrician if your child has consumed this product and you have health concerns

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Baby Allergy Herbal Supplement, Contains: Echinacea Purpurea, Oregon Grape Root, Dandelion & Burdock Root, Fenugreek, Ginger Root in vegetable glycerin; packaged in a 2 oz. glass dropper bottle, UPC 249953949282
UPC code
  • 249953949282
Sold in
AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN
Made for
Infants (0 months and older)

This recall covers 9 products — see all of them.

Details

Units affected
23 bottles
Illnesses reported
None reported
Manufactured in
17745 Us Highway 64, N/A, Somerville, TN, United States
Classification
Class II
Recall number
H-0341-2026

In the FDA's words

Description
Baby Allergy Herbal Supplement, Contains: Echinacea Purpurea, Oregon Grape Root, Dandelion & Burdock Root, Fenugreek, Ginger Root in vegetable glycerin; packaged in a 2 oz. glass dropper bottle, UPC 249953949282 Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label E166SA EXP 4/28 Distribution: AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, TN Affected quantity: 23 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.

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