En esta noticia
The U.S. Food and Drug Administration (FDA) announced a voluntary recall of one lot of Baby Sleep Gripe Water, a liquid dietary supplement sold under the Babies’ Magic Tea brand.
Testing detected ethanol, methanol, and isopropanol that were not listed on the product label, raising potential health concerns for infants.
Pacific Health Sciences announced the recall, which affects only products bearing lot number 25122bw. The supplement was distributed through online retailers, including Amazon and the Secrets of Tea website.
How to identify the recalled baby sleep supplement
The recall covers Babies’ Magic Tea Baby Sleep Gripe Water, packaged in a 4-fluid-ounce (approximately 118-milliliter) amber bottle inside a blue cardboard box. The package also includes an oral syringe.
Parents and caregivers should check the following product details:
- Brand: Babies’ Magic Tea.
- Product: Baby Sleep Gripe Water.
- Lot number: 25122bw.
- Best-before date: December 2028.
- Packaging: 4-fl-oz amber bottle inside a blue cardboard box.
The lot number is printed on the bottom of the box and on a side panel of the bottle. The best-before date alone does not establish whether a product is included in the recall.
Which undeclared alcohols were detected
FDA testing identified three alcohols that were not disclosed on the product label. The approximate concentrations were:
- Ethanol: 8.3%.
- Methanol: 0.35%.
- Isopropanol: 0.48%.
The potential risk depends on the amount consumed and the person’s age and body weight. According to the recall notice, exposure to the amounts recommended on the product’s packaging can cause drowsiness, incoordination, behavioral changes, nausea, vomiting, and abdominal pain.
Higher levels of exposure may increase the risk of respiratory depression and other serious health consequences. The FDA also notes that ethanol exposure in infants has been associated with potential long-term developmental effects.
As of the announcement, Pacific Health Sciences had received no reports of adverse events associated with the recalled lot.
What parents should do if they have the product
The official recommendation is to stop using any product from lot 25122bw immediately. Consumers should either discard the affected supplement or return it to the place of purchase for a refund.
Parents and caregivers should seek medical attention if an infant develops symptoms after receiving the product. They should also contact Pacific Health Sciences to report the issue.
For questions or to report a possible reaction, the company can be reached at 310-457-1775 or by email at myorder@pacifichealth.com. Consumers can also report adverse events through the FDA’s MedWatch program.