When battling a headache, fever, or any number of aches and pains, you may find yourself reaching for Tylenol, a popular over-the-counter option for quick relief. However, the U.S. Food and Drug Administration (FDA) just announced a nationwide recall effort concerning this common drug—here’s how to know if your supply is affected.

The agency’s October 28 enforcement report notice says that 3,186 bottles of Tylenol Extra Strength 500 mg caplets pose a risk to the public due to “defective containers.” The report does not further elaborate why the containers are considered defective, or what consumers should be looking for. The recall was first initiated on October 21 but not publicly announced until Wednesday’s report.

The following product details were provided:

  • Product Name: TYLENOL (Acetaminophen)
  • Strength: Extra Strength – 500 milligrams (mg) per caplet
  • Package Size: 24 caplets per bottle
  • National Drug Code (NDC): 50580-378-04
  • Lot Number: EJA022
  • Expiration Date: 04/30/2028

The pharmaceutical and medical technologies giant Johnson & Johnson Consumer Inc., based in Fort Washington, Pennsylvania, was named as the distributor. Meanwhile, Kenvue Brands of Summit, New Jersey, is the listed recalling firm. In 2021, Johnson & Johnson announced that it was turning its consumer health business into a separate company, now known as Kenvue, according to the Associated Press.

The FDA labeled this recall as a Class II incident, suggesting that the “product may cause temporary or medically reversible adverse health consequences,” but “the probability of serious adverse health consequences is remote.”

On Thursday, Texas Attorney General Ken Paxton announced a lawsuit against Kenvue and Johnson & Johnson—accusing them of misleading consumers and hiding potential risks for pregnant women. Many leading medical experts, including those at Johns Hopkins, maintain that research shows that Tylenol use during pregnancy does not cause autism and “the practical recommendations about how to use Tylenol during pregnancy remain unchanged.”

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