Elevated risk U.S. Food and Drug Administration

Healthy Living Migraine Relief Acetaminophen 250mg, Aspirin 250mg & Caffeine 65mg recall: Device & Drug Safety - Mislabeling

Recall published 2+ years ago

Device & Drug Safety - Mislabeling

Healthy Living Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

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: There is significant risk of misuse which could result in permanent liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol or are allergic to the active ingredient which could be life-threatening.

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

Published
July 18, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Healthy Living
Product type
Prescription & OTC drugs
Sold at
Amazon

Products covered by this recall

Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets

What the company announced

Aurobindo Pharma USA, Inc.: Contact 1-866-850-2876 (Option 2)

Recall being handled by Qualanex: Contact 1-888-504-2014

FOR IMMEDIATE RELEASE – July 18, 2024 – East Windsor, New Jersey. Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets, to the consumer level as sold through Amazon to known within the US market due to the product missing the manufacturer label.

  • NDC No.: 58602-882-21 · Product Name, strength, and pack: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg tablets – 100ct bottles · Lot number: AC2523005A · Expiry: June-2025

Risk Statement: Amazon customers having purchased the above product will have a white unlabeled bottle from the Manufacturer (AuroHealth) bearing only an Amazon identifying sticker, as shown below. As a result, the product lacks the required Over the Counter (OTC) labeling information, drug facts and patient usage information. There is significant risk of misuse which could result in permanent liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol or are allergic to the active ingredient which could be life-threatening. To date, Aurobindo has not received any reports of adverse drug events that are confirmed related to this recall.

Aurobindo Pharma USA, Inc. began shipping of the subject batch to customers nationwide in January 2024. AuroHealth Over the Counter (OTC) bottle(s) with no label affixed to the bottle (i.e. Brite Stock) was inadvertently supplied to Amazon, who then further placed an Amazon sticker with the product name and distributed the OTC product (without the Agency filed and approved label) to end users.

Healthy Living Migraine Relief, Acetaminophen, Aspirin (NSAID) & Caffeine tablets are indicated for temporarily relief of minor aches and pains due to: headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps.

As per the product information leaflet, Healthy Living Migraine Relief, Acetaminophen, Aspirin (NSAID) & Caffeine tablets are “White to off-white, capsule shaped, biconvex film-coated tablet debossed with “T” on one side and “57” on the other side. The product is packaged in 100 count bottles.

The product label affixed by Amazon is as shown below:

Qualanex, on behalf of Aurobindo Pharma USA, Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:

1-866-850-2876 (Option 2), 24 hours per day, 7 days per week; or

[email protected]

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Any general questions regarding the return of this product please contact Qualanex at 1-888-504-2014 (live calls received 7:00 am to 4:00 pm M-F CST).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • AC2523005A

Best-by / use-by date

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

  • June-2025

Establishment number

Inside the USDA mark of inspection on the label.

  • 57

Package size

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

  • 250 mg
  • 65 mg
  • 100 ct
  • 100 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Healthy Living — 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. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  3. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  4. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.

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: Aurobindo Pharma USA, Inc. — Consumers: Aurobindo Pharma USA, Inc., 1-866-850-2876, [email protected]

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 — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Healthy Living prescription & otc drugs recalled?

Device & Drug Safety - Mislabeling There is significant risk of misuse which could result in permanent liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol or are allergic to the active ingredient which could be life-threatening.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AC2523005A; best-by date June-2025; establishment number 57. 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.

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