Shortages of infant and specialty formulas continue to worsen in the US, with the national out-of-stock rate hitting a high of 43 percent in the first week of May, according to data released this week from Datasembly, which tracks retail information.

With bare shelves in stores, purchase limits, and online price gouging and scams, parents across the country are struggling to feed formula-fed babies and children with medical conditions that necessitate specialized formulas. News reports are filled with parents driving hours to search stores for formula or posting pleas online. Some are even watering down formula or turning to recalled batches contaminated with dangerous bacteria.

The dire shortage is due to a combination of factors, including pandemic-related supply chain issues, product recalls, and inflation, according to Datasembly CEO Ben Reich.

While the national out-of-stock rate was relatively stable during the first half of 2021—staying between 2 percent to 8 percent—supply problems began steadily increasing last July and have spiked since February, according to Datasembly.

In February, the situation escalated when the US Food and Drug Administration issued a warning that formula made by Abbott Nutrition’s Sturgis, Michigan, facility could be contaminated with Cronobacter sakazakii or Salmonella Newport bacteria. After the warning, Abbott issued a recall of powder formulas under the Similac, Alimentum, and EleCare labels manufactured in the Sturgis facility.

Four infants—one in Minnesota, two in Ohio, and one in Texas—became ill with Cronobacter infections after consuming formula that came from the facility. The two infants in Ohio died. The FDA and the Centers for Disease Control and Prevention say that the infections “may have contributed to the deaths of [the] two infants.”

In the wake of the recall, the out-of-stock rate for formula hit 30 percent at the beginning of April, then rose to 40 percent by the end of the month. The rise is continuing into May.

Boosting supply

In a statement released Wednesday, Abbott said its review found “no evidence to link our formulas to these infant illnesses.” The company said that it had found Cronobacter in its Sturgis facility, but positive samples came from “non-product contact areas of the facility.” Nevertheless, the FDA provided Abbott with a list of problems it found at the facility, which is currently shut down. Abbott said it is now working on addressing those, including updating cleaning and maintenance procedures as well as retraining employees.

“We know the recall has worsened an already existing industry-wide infant formula shortage in the US and we’ve been seeing and hearing the stress and despair of parents who are facing empty shelves,” Abbott said in its statement. “We deeply regret the situation and since the recall, we’ve been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum. We also began releasing metabolic formulas that were on hold earlier this month at FDA’s request to those who need these unique formulas.”

Abbott reported that getting the Sturgis facility back up and running will require FDA approval, but the company hopes it can be done within the next two weeks. After the restart, it will take six to eight weeks before new formula reaches retail stores.

In a release Tuesday, FDA Commissioner Robert Califf said the agency is doing everything possible to get more formula on shelves.

We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it. Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA. Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.

The FDA said it was taking various steps to boost production, including expediting regulatory reviews for formula makers and expediting certificates for formula imports. The agency also is not objecting to Abbott releasing formula that has been on hold in its Sturgis facility on a case-by-case basis to parents needing urgent, life-sustaining supplies for specialty and metabolic formulas.

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