Kingston Pharma is voluntarily recalling Baby Gripe Water due to the presence of an undissolved citrus flavonoid.
The recall involves all lots of the 4-ounce bottles sold at Dollar General stores across the nation.
Baby Gripe Water is administered orally to infants for relief of gas, colic and teething among other things.
The FDA says there is one report of a one-week old infant having difficulty swallowing when ingesting the product and three complaints linked to the issue.
Consumers are being urged to stop using the product and discard it immediately.