OTC Migraine Relief Tablets Under Class I Recall

Aurobindo Pharma USA Inc., on behalf of AuroHealth, is recalling 240 bottles of Healthy Living migraine relief tablets because bottles sold through Amazon are missing the manufacturer’s label, including drug fact information. The recall was included in the August 28, 2024, US Food and Drug Administration (FDA) Enforcement Report.

On August 20, 2024, the FDA designated the recall Class I. The administration’s most serious drug recall classification, the designation warns use of the product could cause serious adverse health consequences or death.

Without the necessary label, “[t]here 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,” Aurobindo Pharma USA stated in a July 18, 2024, company announcement. “To date, Aurobindo has not received any reports of adverse drug events that are confirmed related to this recall.”

The recall affects Healthy Living migraine relief tablets (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) in 100-count bottles (NDC 58602-882-21) from lot AC2523005A (Exp. 6/30/25). The product was made in India and distributed by Aurohealth, East Windsor, New Jersey. Customers who purchased the product through Amazon received an unlabeled white bottle bearing only an Amazon sticker identifying the product.

“Aurobindo Pharma USA Inc. began shipping of the subject batch to customers nationwide in January 2024,” the company stated. “AuroHealth over the counter (OTC) bottle(s) with no label affixed to the bottle … [were] 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.”

Aurobindo Pharma USA voluntarily initiated the recall on July 11, 2024. The FDA issued its Class I designation on August 20, 2024.
Healthy Living migraine relief tablets are indicated for the temporary relief of minor aches and pains due to headaches, a colds, arthritis, muscular aches, toothache, and premenstrual and menstrual cramps.