Nationwide recall of extra-strength acetaminophen affects 200,000 bottles of pain reliever

Muna Hassan

(Photo from the Food and Drug Administration)

The Food and Drug Administration (FDA) has announced a voluntary recall of nearly 200,000 bottles of extra-strength acetaminophen due to incomplete labeling. This drug is often used for pain and fever relief.

It was announced that A-S Medication Solutions, LLM (ASM) voluntarily recalled Acetaminophen Extra Strength 500 mg tablets that come in 100-count bottles. These bottles were included in Health Essentials Kits that were distributed by Humana to its members nationwide. This distribution likely took place between Jan. 14, 2021, and March 15, 2021.

The expiration dates for these bottles are either July 31, 2022, or Aug. 31, 2022.

The recall is occurring because the bottles have "an incomplete prescription drug label rather than the required OTC Drug Facts label," according to the notice.

To date, no reports of adverse events have been reported, according to the FDA.

These bottles are labeled with National Drug Code (NDC) 50090-5350-0 and were contained in a clear plastic bag that included the white pill bottle as well as Halls cough drops, hand sanitizer, a face mask, a digital thermometer and disposable gloves.

The FDA notes that acetaminophen has the potential to be harmful if safety warnings are not followed. This includes liver damage if "consumers exceed the recommended dose, combine use with excessive consumption of alcohol, or are allergic to the active ingredient."

The notice said, "ASM is also notifying its distributors and customers by mail and is arranging for return of all recalled products. Consumers and distributors that have this product which is being recalled should stop using it and return it in preaddressed return mailers that will be provided by ASM or the distributors."

Those who have questions about this voluntary recall can contact ASM by telephone at 847.680.3515 x 236, from 9-5 p.m. CST, or e-mail at

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Muna has been a journalist and fitness professional for more than 10 years. With degrees in exercise science and dietetics, Muna focuses on informing people about how to lead a healthier lifestyle. Muna is the owner of Body and Mind by Muna, an online gym for at-home workouts, as well as MuslimahFit, a fitness app for women.


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