A supplement meant to calm fussy infants has been recalled after testing by the Food and Drug Administration found that it contained alcohol.
Pacific Health Sciences initiated a recall of its Baby Sleep Gripe Water on Oct. 6, saying the product contained three naturally occurring alcohols that were not disclosed on the label. "Gripe water," a centuries-old herbal remedy that promises to soothe babies with colic and stomach issues, is not regulated by the FDA like medications or foods are.
The presence of these compounds "may pose a risk depending on the amount consumed and the age and body weight of the person using the product," according to the FDA's recall notice. No adverse effects have been reported in relation to the product, which is advertised
for children as young as 2 weeks old.
USA TODAY contacted Pacific Health Sciences for comment on Oct. 8 but has not received a response.
Here's what to know about the recall.
Which baby products were recalled?
The recalled products come in an amber bottle with an oral syringe inside a blue cardboard box. The product's lot number is on the bottom of the box and on the side panel of the bottle.
Secrets of Tea, which received the affected supplement from Pacific Health Sciences, sold it through its website and other online retailers, including Amazon.
- Babies' Magic Tea brand Baby Sleep Gripe Water, 4 fluid ounces: lot number 25122bw; best before 12/2028
What is gripe water? How dangerous are the recalled products?
"Gripe water" is an herbal remedy marketed to help upset stomach and colic, or a baby that chronically cries and cannot be soothed. First formulated in the 1850s, it once contained high concentrations of alcohol – sometimes up to 9%. Now, most mixtures include ingredients like fennel, ginger, dill seed, baking soda, sugar/sweetener and other herbal additives believed to help with digestion, according to Cleveland Clinic. Some may still include small amounts of alcohol.
Gripe water is not FDA-approved or regulated, and although little scientific evidence supports its purported uses, it has remained popular for centuries.
The recalled supplements were found to contain roughly 8.3% ethanol (drinking alcohol), 0.35% methanol (used widely in manufacturing) and 0.48% isopropanol (rubbing alcohol). When given as instructed, these amounts are smaller than what is typically associated with poisoning or intoxication, but still pose a serious risk to infants, who metabolize and handle alcohols differently than adults.
In a hazard statement that was updated on Oct. 7, Pacific Health Sciences said that organic alcohols are "known to impair normal functioning of the central nervous system" and infant exposure has been linked to long-term developmental consequences.
More immediate effects of the medication when administered according to the bottle's instructions could include drowsiness, incoordination, behavioral changes, nausea, vomiting and abdominal pain. Higher doses could cause trouble breathing and "other serious adverse health consequences," according to the company.
What to do with recalled baby supplements
Anyone in possession of the recalled product should stop using it and throw it away or return it to the place of purchase for a refund. If you believe an infant in your care has experienced symptoms related to the product, contact your health care provider.
Health reactions can be reported to Pacific Health Sciences at 310-457-1775 or myorder@pacifichealth.com. Adverse reactions may also be reported to the FDA MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by fax or mail with the form located here, or by calling 1-800-332-1088.
This article originally appeared on USA TODAY: Baby supplement sold on Amazon recalled for containing alcohol
