The products have a “very small amount of belladonna,” according to the FDA, but belladonna “can cause harm at larger doses.”
The FDA did not say how much belladonna they found, only that the amount was not the same as what was on the label.
The recall was issued by Raritan Pharmaceuticals, a company that manufactures homeopathic products that are sold under the Homeolab USA and CVS brand-names. The recalled products include:
- CVS Homeopathic Infants’ Teething Tablet (pulled off store shelves on September 30, 2016)
- Kids Relief Earache Oral Liquid (Homeolab USA)
- CVS Homeopathic Kids’ Ear Relief Liquid
Last month, CVS stopped selling all homeopathic teething tablets and gels after the FDA announced that it was investigating 400 side effect reports, including 10 infant deaths, since another recall in 2010.
The previous recall was issued after the FDA found “varying amounts of belladonna” in Hyland’s Homeopathic Teething Tablets. The products returned to CVS stores within months, but the FDA warned parents not to use them.
Teething starts when a baby is about 6 months old and continues for 2-3 years. Ear aches are another common problem in children under 3 years old. Belladonna is very toxic at that age, and cumulative doses increase the risks over time.
Symptoms of belladonna poisoning include seizures, fevers, shortness of breath, lethargy, constipation, vomiting, sleeplessness, agitation, irritability, and death. Some of these symptoms are easily confused with teething or ear aches, which could lead to a baby being given higher doses of belladonna.
Source: Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall – Possible Belladonna Alkaloids — U.S. Food and Drug Administration (FDA)