Excedrin Migraine & Headache Medication Recall [US]


Excedrin Migraine & Headache Caplets

Click to enlarge image

US FlagUS/Washington: GSK Consumer Healthcare, a Warren, New Jersey establishment, recalls an estimated 433,600 bottles of Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets and Excedrin Tension Headache Caplets from the American marketplace due to reported packaging defects and consequential failure to meet US child resistant closure requirements under the US Poison Prevention Packaging Act with resultant risks of child poisoning, overdose, ingestion and GI tract laceration damage, all serious health and safety hazards.

CPSC: http://ht.ly/O4Qd30rqgVO

Direct link: https://www.cpsc.gov/Recalls/2021/GSK-Consumer-Health-Recalls-Five-Excedrin-Brands-Due-to-Failure-to-Meet-Child-Resistant-Packaging-Requirement-Risk-of-Poisoning

Additional information:
US Consumer Product Safety Commission (“CPSC”) reports this recall involves certain bottles of Excedrin Migraine and Headache Medications, as follows:

  • Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets, and Excedrin Tension Headache Caplets, sold in 50, 80, 100, 125, 200, 250 and 300-count bottles.

Please consult the photograph above for details of the drug’s packaging, design and retail presentation. Additional images of the recalled Excedrin Migraine and/or Headache products can be found on the Web site listed above.

==> No barcodes, UPCs, NDCs, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification. You can see the complete list of recalled drugs on the GSW Web site here: https://www.excedrin.com/products/discontinued.

According to the CPSC, some of the bottles containing these over-the-counter (“OTC”) Excedrin Migraine and Headache medications can have a hole in the bottom. These products contain the substances Aspirin and Acetaminophen which must be sold and stored in child resistant packaging as required by the US Poison Prevention Packaging Act (“PPPA”). Due to the reported defect in these pain mediation products, however, children could access and swallow the contents, posing a serious risk of poisoning.

If you believe you have purchased or have in your possession any of the recalled Excedrin Migraine medications, please do not use them. Instead, immediately store the recalled Excedrin bottles out of sight and reach of children and carefully inspect the bottom of the bottle to determine if there is a hole.

If there is, in fact, this physical defect, please contact GSK Consumer Relations for information on how to receive a prepaid shipping label for return to receive a full refund. The company says bottles without a hole can be retained and used as directed. Alternatively, you can return the product to the store where you purchased it.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to handle poisonings.

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US Centers for Disease Control and Prevention Coronavirus Tips___________________________________________________________

If you have any further questions, comments or complaints about this recall, please contact the GSK Consumer Relations Group toll-free at 1-800-468-7746 from 8:00 AM to 6:00 PM Eastern Standard Time, Monday to Friday. You can also reach the company on the Web at http://www.excedrin.com and click on the “safety issue” banner at the top of the page for more information.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous pain medications, please search for “medications” or more generically, “drugs” using the Search Box at the top of this page.

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==> To see other recalls and notifications relating to Ingestion hazards, please search for “ingestion” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to products made, marketed and/or sold by GSK Consumer Healthcare, please search for “GSK” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to products made, marketed and/or sold under the Excedrin brand, please search for “Excedrin” using the Search Box at the top of this page.

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More information about this recall:
CPSC recall number: 21-057
Recalls Direct RIN: 13915-2020
Want to read more about this recall?
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General information:
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