Healthy Living Migraine Relief Tablets - recalled due to Mislabeling, USA

United States

Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot of Healthy Living Migraine Relief, Acetaminophen, Aspirin & Caffeine tablets to the consumer level due to the product missing the manufacturer label. The product was distributed through Amazon to be known within the US market. Aurobindo Pharma USA, Inc. began shipping of the subject batch to customers nationwide in January 2024.

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 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.

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 temporary relief of minor aches and pains due to: headaches, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps.

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 products recalled are one lot of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets. The product is packaged in 100-count bottles. NDC No: 58602-882-21, Lot number: AC2523005A, Expiry: June-2025.

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.

Company name: Aurobindo Pharma USA, Inc.
Brand name: Healthy Living
Product recalled: Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets
Reason for the recall: Device & Drug Safety - Mislabeling
FDA Recall date: July 24, 2024