Consumers should not buy or use Mommy's Bliss Nipple Cream, marketed by San Rafael, California-based MOM Enterprises, due to ingredients that could harm infants, the US Food and Drug Administration said.
The product, marketed to nursing mothers to help soothe and heal their dry or cracked nipples, contains ingredients chlorphenesin and phenoxyethanol that could cause respiratory distress or vomiting and diarrhoea in infants, the FDA said.
The agency said the company has stated it has discontinued marketing the product. It also said it has not received any reports of injury to infants.
"FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," Dr. Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research, said in a statement.
"Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants," Woodcock said.