FDA Recalls Baby Sleep Gripe Water for Undeclared Alcohol Content

Key points

• The FDA announced the recall of one lot of Babies' Magic Tea Baby Sleep Gripe Water manufactured by Pacific Health Sciences on October 6, 2026.
• Testing revealed the 4 fl. oz. bottles contained approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol, none of which were listed on the label.
• The affected lot, number 25122bw, was sold nationwide on Amazon and other online retailers, with a best-before date of December 2028.
• The FDA noted that the approved limit for ethanol in over-the-counter products for children under six is 0.5%, making the detected levels significantly higher.
• No adverse health events have been reported to date, but parents are urged to discard or return the product for a refund.

Background

Gripe water is a common over-the-counter supplement used to relieve gas and colic in infants, though it is not regulated by the FDA. Recent recalls of other consumer products, such as squishy toys containing hazardous water beads, highlight ongoing concerns regarding the safety of items marketed for children. This incident underscores the lack of strict oversight for herbal remedies, where ingredients and manufacturing processes are largely at the discretion of the manufacturer.

Why it matters

The presence of high levels of undeclared alcohols in a product intended for infants poses a direct safety risk, as the toxicity depends on the amount consumed and the child's weight. This recall highlights the dangers of unregulated supplements and the importance of clear labeling for potentially toxic excipients.

What to watch

Consumers should immediately stop using any product from Lot 25122bw and either discard it or return it to the place of purchase for a refund. Manufacturers and distributors are expected to remove the remaining stock from online platforms to prevent further distribution.