Danone’s Pepticate hypoallergenic infant formula finally makes US debut

By Teodora Lyubomirova

- Last updated on GMT

Getty/Delmaine Donson
Getty/Delmaine Donson

Related tags Infant formula Infant nutrition CMA Cow’s milk Milk breast milk substitute Breastfeeding

The product, made by Danone’s specialized nutrition arm Nutricia, was meant to be available from September 2022 according to initial plans.

But Danone and Nutricia North America told DairyReporter the companies had been actively navigating operational timelines to bring Pepticate to the US market for the first time.

As part of its enforcement drive to improve supply and availability of infant formula in the US, the Food and Drug Administration (FDA) announced on July 29, 2022 a combined total of 74,000 cans from Pepticate Syneo and Pepticate were expected to hit the market in August and September respectively.

But it wasn’t until January 16, 2023 when Pepticate finally became available in the US, we were told. The first shipment totaled 50,000 cans (more than 605,000 8oz bottles) of product, with ‘consistent supply’ expected to follow to meet demand.

Meanwhile, plans are afoot to bring Pepticate Syneo to the US as well, according to Danone and Nutricia.

“This is the first time Pepticate Infant formula has been available in the US,” a spokesperson for Danone and Nutricia said. “We understand how important it is for families to access these specialized formulas which is why our priority has been to increase production and supply of these medical formulas to serve the most vulnerable babies.

“Nutricia’s flagship brand, Neocate, has been available in the US for over 35 years and has gained the trust of families and healthcare professionals in the dietary management of food allergies.

“In order to offer additional nutritional options to families in need of hypoallergenic formula, Danone and Nutricia North America have been working with the FDA to navigate operational timelines in making Pepticate available in the US. In addition to Pepticate…,  Neocate and Aptamil continue to have ample stock available in the US for parents/families who cannot or choose not to breastfeed.”

What is eHF?

Sold in more than 75 countries globally, Pepticate is an extensively hydrolyzed powdered formula (eHF) designed for infants aged 0 to 12 months who suffer from cow's milk allergy (CMA). Though it can be difficult to diagnose, CMA is the most common food allergy in infancy, affecting roughly 75,000 infants each year*. It can be responsible for a wide range of symptoms like rashes, diarrhea, vomiting and colic. 

In an eHF formula, the allergy-triggering milk proteins have been hydrolyzed into peptides to ensure the product is tolerated by most infants with cow milk protein allergy. According to Danone, eHFs are effective in over 90% of cases of mild-to-moderate CMA.


Pepticate is available for purchase online via Amazon and Pepticate.com and is also distributed nationally through Nutricia North America within medical and retail channels that include National & Regional Home Health Care & Durabel Medical Equipment and State & Government Programs. The cost of the newly-imported product is comparable to other specialized hypoallergenic formulas sold in the US, we were told.

World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) Guidelines
Alessandro Fiocchi et al.
Published: Pediatr Allergy Immunol. 2010 Jul;21 Suppl 21:1-125
DOI: 10.1111/j.1399-3038.2010.01068.x

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