Vietnam recalls US-made ByHeart Infant Formula after botulism cases

The Vietnam Food Safety Authority (VFSA) under the Ministry of Health issued the order on Thursday in an official dispatch sent to provincial and municipal health departments, the Ho Chi Minh City Department of Food Safety, and local food safety units.

The action follows alerts from the World Health Organization (WHO) and the International Food Safety Authorities Network about a risk of infant botulism tied to contaminated ByHeart formula produced by U.S.-based ByHeart Incorporated.

According to WHO data, as of Wednesday, the U.S. Centers for Disease Control and Prevention (CDC) had documented 31 suspected and confirmed cases of infant botulism linked to the product.

Botulism is a rare but serious illness, caused by a toxin from the bacterium Clostridium botulinum, which attacks the body’s nerves and can lead to difficulty breathing, muscle paralysis, and even death, the CDC said.

In infants, symptoms may include difficulty feeding or choking, constipation, weak sucking, drooping eyelids, reduced facial expression, a weak cry, inability to hold up the head, and muscle weakness or floppiness in the upper body and limbs.

ByHeart has launched a voluntary recall covering all batches in the U.S., and parents there have been urged to stop using the formula immediately regardless of lot number, packaging type or can size.

To protect consumers in Vietnam, the VFSA has instructed local agencies to urgently review the product’s registration and self-declaration status.

Officials must work with any companies involved in importing or distributing the formula to notify partners and consumers to halt use.

Agencies have also been told to carry out recall procedures in line with the manufacturer’s instructions and report the quantities imported, sold, and remaining in storage, along with proposed handling measures.

Local authorities have been urged to step up public communication to warn consumers against using any ByHeart Whole Nutrition Infant Formula still on the market.

They must promptly report and address any cases in which the product remains on sale.

The CDC has noted that botulism symptoms may take weeks to appear and has urged parents and caregivers to closely monitor children who may have been exposed.

Earlier this month, the CDC expanded the recall to include all ByHeart formula products as cases continued to rise across multiple U.S. states.

No deaths were reported at that time.

The CDC said the formula is sold online and through major U.S. retail chains.

Consumers who bought the recalled product have been advised to record the batch number if possible before discarding or returning it and to seek medical care immediately if their child shows any symptoms of botulism.