Class II U.S. Food and Drug Administration

A New Life Herbs, LLC Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5 recall: Unapproved drug claims on product labeling and product misbranded

Recall published 10 months ago

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

The hazard: Mislabelling or misbranding

The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

What the notice says: Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
H-0345-2026
Published
December 31, 2025
Risk level
Class II
Status
Terminated
Issued by
U.S. Food and Drug Administration
Brand
A New Life Herbs, LLC
Product type
Dietary supplements
Units affected
22 bottles
Distribution
Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York, Tennessee
Made in
United States
Lot / code info
T553MF EXP 12/28

Products covered by this recall

Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic dropper bottle

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12
  • 28 — 22 bottles

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.5 oz

Codes are lifted verbatim from the FDA — Food & cosmetics enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

A New Life Herbs, LLC — The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  3. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  4. Check the lot code on your pack — these mix-ups are usually confined to a short production window.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: A New Life Herbs, LLC — 17745 Us Highway 64, Somerville, TN, 38068-6163

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Food & cosmetics enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was A New Life Herbs, LLC dietary supplements recalled?

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 12 or 28 — 22 bottles. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Which states were affected?

The notice lists Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York, Tennessee.

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