The pills were labeled with the wrong drug facts, according to the FDA, which could lead to overdose or other complications.
An Over-the-Counter Pain & Fever Medicine Has Been Recalled Nationwide
Updated Sep. 09, 2024
It’s reported a drug maker based in Illinois is scrambling to reach customers after a labeling mixup that could put some consumers in danger.
If you typically turn to Tylenol or any other brand of acetaminophen products to relieve your pain, you’ll want to check some details. The US Food and Drug Administration (FDA) has announced that Libertyville, IL-based A-S Medication Solutions LLC is working via email, fax, letter, telephone calls, and in-person visits to alert buyers that their 500 milligram acetaminophen pain reliever may have been mislabeled with drug facts that represent those of 81 milligram aspirin, also commonly referred to as “baby aspirin.”
This affects 429 bottles of acetaminophen product that were distributed nationwide with the reported lot code 4138197 and expiration date of 10/31/2025. While no specific retailer is named as the seller(s), this follows a 2021 recall for nearly 200,000 bottles of acetaminophen made by the same company that USA Today reported had been distributed to Humana health plan members.
So what’s the danger of mixing up aspirin and the active ingredient in Tylenol? A big one is dosage. Five hundred milligrams of acetaminophen tends to be a generous dose, with higher dosages typically requiring prescription. One reason is that the drug can be hard on the liver. A consumer who reads the bottle and believes they’re taking only 81 milligrams, as baby aspirin labels suggest, could easily try to multiply that dosage to get faster or more effective pain relief, only to overdose.
Another difference between the two, as the University of Tennessee Medical Center explains, is that aspirin is an anti-inflammatory. In contrast, acetaminophen’s mechanism is not to minimize inflammation, but instead to alter how the body perceives pain.
The recall was originally initiated in June 2024, but this week the FDA has given it a Class I risk level, meaning using the drug could lead to serious health consequences or death.
| What Each FDA Recall Classification Means | |
| Class I Recall | “A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” |
| Class II Recall | “A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” |
| Class III Recall | “A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.” |
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- More Than 120,000 Bottles of an Oatmeal Moisturizer Recalled USA Nationwide
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Originally Published: August 14, 2024
