Health
Nationwide Recall Issued for Over The Counter Pain Medications Due to Labeling Error
You may have been drawn to Amazon’s convenient and cost-effective platform for stocking up on household necessities, including the popular over-the-counter (OTC) drugs like aspirin and acetaminophen. However, it’s time to scrutinize your recent OTC drug purchases from Amazon, especially if you discover bottles bereft of necessary labels. A migraine medication sold nationwide is now under recall due to labeling issues.
On July 24, Aurobindo Pharma USA, Inc. voluntarily initiated a nationwide recall of their product, Healthy Living Migraine Relief, Acetaminophen 250 mg, Aspirin (NSAID) 250 mg, and Caffeine 65 mg tablets. The recall comes on behalf of AuroHealth and was triggered by grave concerns over mislabeling, as reported by a notice from the U. S. Food & Drug Administration (FDA).
This recalled medication, which hit the market in January 2024, was readily available for customers on Amazon. According to the release, the tablets are purposed to provide temporary relief from discomfort caused by various conditions, including headaches, colds, arthritis, muscle aches, toothaches, and cramps during premenstrual and menstrual periods.
Recognizing the Healthy Living Migraine Relief tablets is simple; they are “white to off-white, capsule-shaped, biconvex film-coated tablet debossed with ‘T’ on one side and ’57’ on the other side” and are typically packaged in 100-count bottles.
AuroHealth’s error lies in supplying Amazon with unmarked white bottles devoid of the essential OTC labeling information, drug facts sticker, or patient usage information, which are mandatory per FDA regulations.
Poison Control stipulates, “Every OTC medicine has a Drugs Facts Section. This is required reading before giving or taking a medicine.” They further explain that all products, from toothpaste tubes to allergy medication bottles, must display key information in a particular order: active ingredients, product’s purpose, product’s uses, specific warnings, dosage instructions, and inactive ingredients.
Unfortunately, Amazon merely affixed each bottle with “an Amazon identifying sticker” that sported the product name. Consumers were then shipped these mislabeled OTC medications, which could potentially lead to severe–sometimes fatal–health implications.
According to the recall notice, misuse of the product can lead to a “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.”
If you possess this product, Aurobindo Pharma advises that you can verify whether your purchase is impacted by the recall by referring to the National Drug Code (NDC) and lot number. Affected OTC medications will carry a 10-digit NDC that reads “58602-882-21” and a lot number “AC2523005A.” The bottles also bear a “June-2025” expiration date.
In case you have been taking this OTC drug or have experienced abnormal health effects while using it, it’s recommended to reach out to your healthcare provider for immediate medical assistance. Should you need to put forth queries about the recall or report an adverse event, Aurobindo Pharma has a 24-hour hotline (1-866-850-2876, Option 2) and can be reached via email at pvg@aurobindousa.com.
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