Several Excedrin® Products Recalled Due to Manufacturing Defect

If you take over-the-counter Excedrin®, you should check your bottle to see if it was affected by a recent manufacturing defect. Several Excedrin products were recalled in late December 2020 for not meeting the child-resistant packaging requirement. More than 433,000 bottles were affected by the recall, which was issued by the makers of Excedrin, GlaxoSmithKline (GSK).1

It is important to note that this is an actual recall and not to be confused with a prior Excedrin issue, which was a shortage.

Which products were recalled?

The Excedrin products that were affected include specific lots of the following products in 50, 80, 100, 125, 200, 250, and 300-count bottles:1,2

  • Excedrin Migraine Caplets
  • Excedrin Migraine Geltabs
  • Excedrin Extra Strength Caplets
  • Excedrin PM Headache Caplets
  • Excedrin Tension Headache Caplets

Excedrin Extra Strength caplets and Excedrin Migraine caplets and geltabs in 24-count bottles are not affected by this recall.2

Why were the products recalled?

The affected bottles were recalled because they may have a hole in the bottom of them. Although no injuries or incidents have been reported as of January 2021, bottles with a hole in them put children at risk. This is because children can potentially access and ingest the medicine, which can lead to poisoning. Excedrin contains the ingredients aspirin and acetaminophen. These ingredients are required to be in child-resistant packaging under the Poison Prevention Packaging Act (PPPA).1

The PPPA of 1970 requires child-resistant packaging for certain household substances. Packaging must be difficult for children under 5 years old to open within a reasonable amount of time, while not difficult for normal adults to use.3

For people who need easier-to-open bottles, manufacturers must offer child-resistant packaging but can also package these products in 1 non-compliant size, as long as it has a warning that it should not be used in households with children. Under the PPPA, prescription drugs can be dispensed in non-child-resistant packaging when requested by the doctor or patient.3

Since the PPPA has been in effect, there has been a large decrease in children’s deaths from accidental ingestion of household products, including medicine.3

What should I do if I have Excedrin that has been recalled?

If you have a bottle of Excedrin that has been affected by the recall, immediately store the bottle out of sight and reach and children. Inspect the bottom of the bottle to see if there is a hole. Bottles without a hole can be saved and used as directed. If there is a hole in the bottom of the bottle, contact GlaxoSmithKline (GSK), the makers of Excedrin, for information on how to receive a prepaid shipping label to return the bottle for a full refund.1

As of January 2021, generic versions of Excedrin are still available. If you are looking for an Excedrin product that has been recalled, ask your pharmacist if they stock a generic version.

For more information about the recall, you can call GSK Consumer Relations at 800-468-7746 or visit the GSK website.

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