It's best known as the active ingredient in Tylenol, but the capsule and tablet forms of an off-brand name pose an issue that could cause confusion.
Over 20,000 Bottles of a Pain & Fever Reducer Have Been Recalled Nationwide
Published on Jan. 14, 2025
Think of how often a little pain, a headache, or a fever make you reach for over-the-counter relief. National consumer healthcare data suggests that every week, 52 million Americans—that’s 23% of the population—use a medication that contains the pain reliever and fever reducer acetaminophen. This over-the-counter (OTC) ingredient can be found in hundreds of medications, including some cold and flu relievers and several cough suppressants, but it’s best known for being the active ingredient in Tylenol.
A recent series of nationwide recalls first announced in December by the U.S. Food and Drug Administration (FDA) highlighted a production problem which affected 23,254 bottles of a generic acetaminophen in both tablet and capsule form, which were distributed by Akron Pharma in Fairfield, NJ. According to the recall announcements, the affected capsules and tablets were imprinted with the wrong identification code.
The affected medications were distributed in 500-milligram (mg) and 325 mg bottles, reportedly containing either 100 or 1,000 pills per unit. They can be identified using the following lot numbers and expiration dates:
- Lot Number: KDT0224002A, Exp. Date: September 30, 2026
- Lot Number: KDT0124001, Exp. Date: August 31, 2026
- Lot Numbers: KDT0124004, KDT0124005, KDT0124006, Exp. Date: August 31, 2026
- Lot Numbers: KDT0224001B, Exp. Date August 31, 2026; KDT0224002B, Exp. Date: September 30, 2026
The FDA cites reason for the recall as “Not Elsewhere Classified” (NEC)—meaning it happens rarely enough that there is no predetermined code for the error. The agency suggests the event is unlikely to pose a serious threat to consumers—in a January 10 update to the December notice, the FDA designated the incident a Class III recall, which suggests it is “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
However, Harvard University medical school’s blog notes that many individuals who rely on the appearance of pills to identify them and could run into a problem if for any reason they include acetaminophen as part of their regular regimen. For instance, if consumers remove the medication from its original packaging and place it in a pill sorter, it could become confusing when it comes time to actually take them. “Medication mix-ups and mistakes sometimes lead to harmful drug reactions, which cause about 700,000 emergency department visits and 100,000 hospital admissions each year,” a post shares.
If you believe you have purchased the affected medications, return them to your place of purchase, or talk to a doctor or pharmacist with any questions.
Acetaminophen is commonly used in the treatment of minor aches and pains, such as headache, backache, arthritis, toothache, muscle aches, and menstrual cramps. Though it is generally considered safe and effective when taken in the recommended doses, taking too much can lead to severe liver damage or death.
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