Abbott has stopped production of its infant formula at its Sturgis, Mich., plant less than two weeks after restarting due to severe thunderstorms that caused flooding inside the plant.
The company announced the pause in production in a statement on Wednesday, adding that it will re-sanitize the plant and production is likely to resume in a few weeks.
"Severe thunderstorms and heavy rains came through southwestern Michigan on Monday evening, resulting in high winds, hail, power outages and flood damage throughout the area. These torrential storms produced significant rainfall in a short period of time – overwhelming the city's stormwater system in Sturgis, Mich., and resulting in flooding in parts of the city, including areas of our plant," the company said.
"As a result, Abbott has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitize the plant," it added.
The company said it has informed the Food and Drug Administration and will conduct comprehensive testing to ensure the facility is safe to resume production.
"This will likely delay production and distribution of new product for a few weeks," Abbott said.
Abbott says there is ample supply of specialty formulas despite the plant closure
The company had just announced the reopening of the plant on June 4 and planned on releasing the EleCare formula to consumers on June 20. But even with the latest pause in production, the company says it "has ample existing supply of EleCare" and other specialty formulas to last consumers until more is available.
Production of EleCare — formulated for infants with allergies to cow's milk – had been stopped at the Sturgis plant since February when the plant closed following a Cronobacter sakazakii bacterial contamination.
Abbott also issued a voluntary recall of EleCare and other specialty formulas in mid-February after learning four infants had become sick with bacterial infections and had consumed products made at the Michigan plant. Two infants ultimately died.
The recall only exacerbated a larger nationwide shortage of baby formula that has been a major stressor for parents for months.
To ease the strain, the Biden administration has been working with manufacturers to import formula from overseas. President Biden also invoked the Defense Production Act in May to help production in the U.S.
Abbott says it is nearly back at the production level of formula it saw in January despite the Sturgis plant being out of commission.
Dr. Robert M. Califf, the commissioner of the Food and Drug Administration, said on Twitter that the storm was "an unfortunate setback." He added that the measures already taken mean the U.S. should have enough product to meet demand and that the FDA and Abbott both want to get the facility up and running again in a quick and safe manner.
"We know Abbott is working quickly to assess the damage and will be reporting its progress to us in the days ahead," Califf said. "Once the company establishes a plan, FDA will be back in the facility working to ensure that they can restart producing safe and quality formula products quickly."