The Recall Desk
HighCPSC·21057·Announced 2020-12-23

GSK Recalls Five Excedrin Brands Due to Child-Resistant Packaging Defects

GSK Consumer Healthcare is recalling five Excedrin brands because some bottles have holes in the bottom, posing a risk of poisoning to children.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (poisoning) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GSK Consumer Healthcare is recalling approximately 433,600 bottles of Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets, and Excedrin Tension Headache Caplets. The recall involves 50, 80, 100, 125, 200, 250, and 300-count plastic bottles with child-resistant closures. These products were sold at pharmacies, department stores, grocery stores, and hypermarkets nationwide and online from March 2018 through September 2020 for between $7 and $18.

The recall is due to a failure to meet the child-resistant packaging requirement under the Poison Prevention Packaging Act. Some bottles may have a hole in the bottom, which could allow children to access and swallow the contents. The products contain aspirin and acetaminophen, which pose a risk of poisoning if ingested by children. No injuries have been reported.

Consumers should immediately store the recalled bottles out of sight and reach of children and inspect the bottom of the bottle for holes. If a hole is found, consumers should contact GSK Consumer Relations at 800-468-7746 or visit www.excedrin.com to receive a prepaid shipping label for a full refund. Bottles without a hole can be retained and used as directed.

The recalled product

Product
Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets, and Excedrin Tension Headache Caplets
Manufacturer
GSK Consumer Healthcare, of Warren, N.J.
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
433,600

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · poisoning

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