The campaign, created by McCann Erickson, which won the account in August this year, features a man standing in front of the Viagra logo. The tips of the letter "V" form devil's horns and the copy reads: "Remember that guy who used to be called 'Wild Thing'? ... he's back."
The FDA argues that the ad does not explain what the medication is for, nor warn of any potential side-effects.
Pfizer has indicated that it will comply with the FDA's request.