Raritan Pharmaceuticals voluntarily issued a recall of its children’s homeopathic ear relief liquid and teething tablets that contain belladonna extract.
The Raritan products recalled include CVS Homeopathic Infants’ Teething Tablet, Kids Relief Homeopathic Ear Relief Oral Liquid and CVS Homeopathic Kids’ Ear Relief Liquid. These products are distributed nationwide.
After the FDA tested a few of the recalled products, they found they contained levels of belladonna extract that varied from what the labels stated. When consumed in large doses, belladonna — a toxin from a poisonous plant called deadly nightshade — can be fatal.
Raritan Pharmaceuticals maintains that the recall is only precautionary and that consumers should not worry.
“The recall is a precautionary action,” Sushant Pradhan, a Raritan Pharmaceuticals representative told CNN.
Pradhan also told CNN that the recalled products only contained a nanogram of belladonna, which he assured is “not toxic to the anybody.” According to Pradhan, the company has yet to receive the recent belladonna test results from the U.S. FDA.
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In September, the FDA warned consumers against using homeopathic teething tablets and gels after 10 deaths were reported. The cause of those deaths is uncertain, but the agency suggested that the homeopathic teething tablets contain possibly harmful doses of belladonna.
After the FDA warning in September, Hyland’s, a maker of homeopathic teething tablets and gels, discontinued distributing their teething products.
“Our Baby Teething Tablets, like all Hyland’s branded homeopathic medicines, are made in facilities that follow current Good Manufacturing Practices and are inspected by the FDA in the same way as other OTC drugs are,” a statement on the Hyland’s website read. “You may use them with confidence. We test our products for their belladonna content as well as other tests including microbial contamination. We also have a program to monitor, investigate, and trend all safety reports on any of our products.”
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Many homeopathic treatments contain a small amount of belladonna, which is safe to consume. But belladonna poisoning can happen when larger doses are ingested. The symptoms could include seizures, difficulty breathing, lethargy and excessive sleepiness, according to the FDA.
Retailers such as CVS and Walgreens took the products off their store shelves before the Rarity Pharmaceutical products recall was issued.
The FDA advises consumers of the recalled products to stop using them immediately. If consumers have any health concerns or problems, they should call their physician or health care providers.
Danielle Tarasiuk is a multimedia journalist based in Los Angeles. Her work has been published on AllDay.com, Yahoo! Sports, KCET, and NPR-affiliate stations KPCC and KCRW. She’s a proud Sarah Lawrence College and USC Annenberg alumn.
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