Popular supplements touted for alleviating nighttime cramps, lowering blood pressure and boosting heart health have been urgently recalled.
The FDA has warned of an urgent recall of 13,920 bottles of Adndale Magnesium Glycinate Gummies because they may contain melatonin, a hormone that regulates sleep.
Naturally produced in the brain’s pineal gland, melatonin controls the body’s sleep-wake cycle, otherwise known as the circadian rhythm.
While melatonin supplements are generally considered safe, it’s unclear exactly how much of the sleep supplement was found in the magnesium gummies. High doses have been tied to poisoning deaths, especially in children, as well as heart failure.
The recall was given a Class II designation, which indicates ‘a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.’
There have been no illnesses or adverse effects linked to the recalled supplements.
Adndale Magnesium Glycinate Gummies subject to the recall were sold in 90-count 11.4oz plastic bottles on the brand’s website and third-party online retailers such as Amazon.
The supplements contain 400mg magnesium, according to the label, and have a serving size of two gummies.
Nearly 14,000 bottles of magnesium supplements were recalled due to potentially containing undeclared melatonin (stock image)
The recall includes the lot numbers 190824, 240923 and 240929, which have expiration dates of August 19, September 22 and September 28, 2026, respectively.
Recalled products have the UPC 860008784551 printed on the label.
The FDA has not issued specific guidance for disposing of or stopping use of the supplements, but the agency typically recommends immediately throwing recalled supplements out or returning them to the place of purchase.
Magnesium is an essential mineral regulating over 300 biochemical reactions in the body, such as muscle and nerve function, blood pressure and glucose control.
It’s found naturally in dark leafy greens, nuts, seeds, legumes and whole grains.
Magnesium glycinate, the form in the recalled supplements, has been shown to improve sleep quality, as it helps regulate brain chemicals involved in relaxation and wakefulness.
It also helps naturally produce melatonin and relax muscles, which helps treat leg cramps at night.
These benefits can help promote a restful night’s sleep, but compounded with additional melatonin, users may experience excess drowsiness.
Recent studies have also pointed to potential dangers linked to melatonin supplements.
In a study published last year, researchers found that, compared to people with insomnia who didn’t take the sleep supplement, melatonin users were 90 percent more likely to be diagnosed with heart failure within five years.
Users were also three times more likely to be hospitalized for heart failure than their peers who didn’t take it.
And those who used melatonin were nearly twice as likely to die from any cause in five years compared to non-users.
However, experts have stressed that it is important to note the findings showed only associations, not direct causes.
Additionally, in 2022, the CDC revealed how, in the decade leading up to 2021, poison helplines dealt with 260,435 calls about children who had taken too much melatonin – a 530 percent increase from 2012.
In 2012, melatonin was responsible for one percent of pediatric poisonings. That rose to five percent in 2021.
Of the poison reports, two children died, five were put on a ventilator to help them breathe, nearly 300 ended up in intensive care and more than 4,000 were hospitalized.
