Even though the Food and Drug Administration warned the public in 2016 about elevated levels of belladonna, a potentially dangerous toxin, in homeopathic teething tablets produced by Hyland’s — and then confirmed this risk in January — the products remained on store shelves and in family’s medicine cabinets. Now, under pressure from the FDA, Hyland’s has officially issued a recall for all of its homeopathic teething products.

Most homeopathic products are so diluted that they contain virtually no, if any, detectable level of the original ingredient. However, FDA research found dangerously high, and inconsistent, amounts of belladonna in the Hyland’s tablets. The agency received numerous reports from families and physicians about apparent adverse reactions to these products, ranging from bumpy rashes to listlessness to seizures.

Hyland’s stopped selling its teething products in the U.S. in Oct. 2016 after the first FDA warning resulted in CVS pulling the items from stores. Yet, discontinuing a product is far different from issuing a recall. At the time, Hyland’s insisted the tablets were safe.

Given the potential for risk posed by teething tablets still in homes and stores, the FDA recently wrote to Hyland’s parent company, Standard Homeopathic, urging it to finally issue a recall.

“The FDA has determined that the inconsistent amounts of belladonna alkaloids found in these products produced by Standard Homeopathic Company represent a serious health hazard,” reads the letter [PDF]. “Pharmacologic response to belladonna in the target population for these products is unpredictable and puts them at unnecessary risk.”

The FDA can’t just recall a product on its own, but it can take action against a company that refuses to recall a product proven to be unsafe. With that threat dangling over its head, Standard Homeopathic officially recalled all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets:

If you have any of these products, you should not use them but contact Standard Homeopathic by calling 1-800-991-3376 (Monday-Friday 6 a.m. to 4 p.m. Pacific Time).

Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to taking or using this drug product.

This is the second time in a decade that Hyland’s has recalled teething tablets over belladonna concerns. The company issued a recall in 2010, but according to recent FDA reports, many parents continued to use the products because they did not know at the time that the tablets had been recalled.

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