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Simply Sleep FDA Alerts

The FDA Alert(s) below may be specifically about Simply Sleep or relate to a group or class of drugs which include Simply Sleep (diphenhydramine).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for diphenhydramine

McNeil Consumer Healthcare Over-The-Counter Products: Recall

Jan 15, 2010

Audience: Consumers, Pharmacists

McNeil and FDA notified healthcare professionals of an expansion of the December 2009 recall. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints. Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. The affected product names and lot numbers for the recalled products can be found in firm's Press Release. Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

[01/15/2010 - Press Release - McNeil Consumer Healthcare]
[12/18/2009 - Press Release - McNeil Consumer Healthcare]

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