WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced a voluntary recall by Aurobindo Pharma USA, Inc. for one lot of Healthy Living Migraine Relief tablets. The recall affects Acetaminophen 250mg, Aspirin (NSAID) 250mg, and Caffeine 65mg tablets sold through Amazon. The recall is due to the absence of a manufacturer label on the product.
The recalled product, listed under lot number AC2523005A and with an expiry date of June 2025, was shipped nationwide starting January 2024. Consumers who purchased the product received a white bottle with only an Amazon identifying sticker, lacking the required Over the Counter (OTC) labeling information, drug facts, and patient usage guidelines.
This labeling omission poses significant risks. Consumers may misuse the product, leading to permanent liver damage if they exceed the recommended dose, mix it with excessive alcohol, or are allergic to the active ingredients. These risks make it crucial for consumers to have access to proper labeling and information.
To date, Aurobindo has not received any reports of adverse events related to this recall. However, the company emphasizes the importance of halting distribution and returning the affected products. Distributors and customers are being notified to discontinue distribution and return the recalled items.
The Healthy Living Migraine Relief tablets in question are white to off-white, capsule-shaped, biconvex film-coated tablets, debossed with “T” on one side and “57” on the other. They are packaged in 100-count bottles and indicated for the temporary relief of various minor aches and pains, including headaches, arthritis, and menstrual cramps.
For consumers with questions or adverse event reports, Aurobindo Pharma USA, Inc. can be contacted at 1-866-850-2876, available 24/7, or via email at pvg@aurobindousa.com. General questions regarding product returns can be directed to Qualanex at 1-888-504-2014, available Monday to Friday from 7:00 am to 4:00 pm CST.
Adverse reactions or quality problems can also be reported to the FDA’s MedWatch Adverse Event Reporting program online or by regular mail and fax. Forms and instructions are available at www.fda.gov/MedWatch.
The FDA and Aurobindo Pharma USA, Inc. urge consumers to check their medicine cabinets and ensure they are not using the affected product to prevent potential health risks.
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