Health officials say certain teething gels can cause rare, but deadly side effects.
Benzocaine products are sold as gels, sprays, ointments, solutions and lozenges under brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex and as store brands and generics.
If manufacturers fail to comply, then the FDA will issue a regulatory action to remove these products from the market.
The FDA added that the agency has been warning against using OTC teething medications for the last decade, however infant deaths linked to benzocaine continue to be reported.
Benzocaine can cause a serious health threat called methemoglobinemia, which greatly reduces the level of oxygen carried through the blood.
Scott Gottlieb, the FDA commissioner, recently proclaimed about the sunscreen products.
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They advise speaking with your doctor before using them especially if you have heart disease, are elderly, a smoker or have breathing problems such as asthma or emphysema.
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The child can start showing symptoms of methemoglobinemia in few minutes after using these products. Anyone with these symptoms should seek medical attention immediately, according to the FDA.
The American Academy of Pediatrics has informed parents to use alternatives such as hard rubber teething products.
The headline was followed with, "Agency urges companies to discontinue teething products, include new warnings for other OTC benzocaine products and revise warnings for approved prescription local anesthetic drugs".
"Here you have a product that doesn't really help and can induce harm", says Meeks.
The FDA has warned against the use of teething products containing a substance that can "pose a serious risk" to infants and children.