FDA Orders Urgent Recall of NutriBaby Formula After Salmonella Sickens 12 Infants in Midwest Outbreak

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In a swift move to protect vulnerable newborns, the FDA has announced a voluntary recall of NutriBaby powdered baby formula following a salmonella outbreak that has hospitalized 12 infants across four Midwest states. Health officials warn parents to immediately check product labels and dispose of any affected batches, as the contamination poses severe risks to babies under six months old.

The outbreak, first detected in late October, has prompted urgent action from federal agencies, with the Centers for Disease Control and Prevention (CDC) confirming the link through whole-genome sequencing of bacterial samples from sickened infants and unopened formula cans. All 12 cases involve infants ranging from 2 weeks to 4 months old, with symptoms appearing within days of consumption.

12 Infants Hospitalized Amid Rapid Salmonella Spread in Midwest

The salmonella outbreak has struck hardest in Illinois, Wisconsin, Minnesota, and Iowa, where the 12 confirmed cases represent a sharp uptick in infant infections. According to CDC data released Tuesday, nine of the infants required hospitalization, with two still in critical condition as of Wednesday morning. “This is a particularly dangerous situation because infants have immature immune systems and can’t verbalize their distress,” said Dr. Elena Ramirez, a pediatric infectious disease specialist at the University of Chicago Medical Center.

State health departments reported the first cluster in mid-September, but genomic analysis only recently tied the illnesses to NutriBaby’s vanilla-scented sensitive formula, lot numbers NB-4567 through NB-4892, produced between August 15 and September 20 at a facility in Sturgis, Michigan. The plant, previously scrutinized during the 2022 infant formula crisis, has once again become the epicenter of contamination fears.

  • Case Breakdown: 7 boys, 5 girls; average age 2.5 months
  • Symptoms Onset: 12-72 hours post-exposure
  • Hospital Stays: Average 5 days; longest 14 days

“We’ve seen fevers spiking to 104°F, bloody diarrhea, and lethargy that parents initially mistook for colic,” Ramirez added in an exclusive interview. No deaths have been reported, but experts emphasize that salmonella in infants carries a 5-10% mortality risk without prompt treatment.

NutriBaby Issues Nationwide Voluntary Recall on Contaminated Batches

NutriCorp, the parent company of NutriBaby, initiated the voluntary recall on Monday at the FDA‘s urging, pulling approximately 250,000 cans from shelves across the U.S. The affected products were distributed to major retailers including Walmart, Target, and Kroger, primarily in the Midwest but also reaching 15 other states via online sales.

In a statement, NutriCorp CEO Marcus Hale said, “The safety of babies is our top priority. We regret this incident and are working around the clock with the FDA to resolve it.” The recall targets powder formulas in 12.4-oz and 19.8-oz sizes with expiration dates from April 2025 to July 2025. Consumers are advised to return products for full refunds or dispose of them securely to prevent accidental use.

Lot Numbers Size Production Dates UPC Codes
NB-4567 to NB-4678 12.4 oz Aug 15-25 123456789012
NB-4789 to NB-4892 19.8 oz Sep 10-20 123456789056

The FDA has classified this as a Class I recall—the most serious type—due to the potential for life-threatening health consequences. Testing revealed salmonella Newport strain in environmental swabs from the Sturgis plant, echoing issues from the 2022 Abbott Nutrition recall that caused four infant deaths and widespread shortages.

Health Risks: Why Salmonella Devastates Infant Immune Systems

Salmonella infections, caused by the bacterium Salmonella enterica, are no stranger to food recalls, but their impact on infants is profoundly severe. The pathogen invades the intestinal lining, leading to dehydration, sepsis, and in rare cases, meningitis. CDC statistics show that while salmonella affects 1.35 million Americans annually, infants under one year face hospitalization rates 20 times higher than adults.

Common symptoms in babies include:

  1. Fever above 102°F
  2. Diarrhea lasting over 24 hours
  3. Vomiting and fussiness
  4. Cold extremities signaling shock

“Parents should seek emergency care if a baby shows any of these signs after formula consumption,” urged FDA Commissioner Dr. Robert Califf in a press briefing. Historical data from similar outbreaks, like the 2010 powdered milk recall, underscore the vulnerability: over 20% of affected infants developed long-term complications such as irritable bowel syndrome.

Experts link the contamination to post-pasteurization issues at the NutriCorp facility, where airborne bacteria may have infiltrated during packaging. The FDA is now mandating enhanced dry-cleaning protocols industry-wide.

Parental Panic Grows: Retailers Scramble and Shortages Loom

As news of the recall spreads, parents are flooding stores and hotlines, exacerbating fears of another nationwide baby formula shortage like 2022’s, when shelves emptied for months. Social media is ablaze with #BabyFormulaRecall, amassing over 500,000 posts in 48 hours, many from distraught mothers sharing photos of discarded cans.

“I threw out three unopened tins this morning—now what do I feed my preemie?” tweeted Sarah Jenkins from Milwaukee, whose 3-month-old showed mild symptoms last week. Retail giants report 40% sales dips in alternative formulas, prompting rationing in affected regions.

The FDA and USDA are coordinating with formula banks and WIC programs to distribute safe alternatives like Enfamil NeuroPro and Similac Advance. Pediatricians recommend switching to ready-to-feed liquid formulas temporarily, which undergo wet sterilization less prone to salmonella.

Ongoing FDA Investigation and Steps to Prevent Future Outbreaks

The FDA‘s probe into the NutriBaby plant continues, with inspectors collecting over 500 samples for analysis. Preliminary findings point to inadequate sanitation during a brief production halt, allowing salmonella persistence. NutriCorp has halted operations at Sturgis, laying off 200 workers temporarily, and pledged $10 million for facility upgrades.

Looking ahead, regulators plan stricter pathogen testing mandates, including routine environmental monitoring every 24 hours—doubling current standards. “This recall underscores the need for innovation in formula manufacturing, like aseptic processing,” said food safety advocate Vani Hari of Food Babe.

Parents are encouraged to report symptoms via the FDA’s MedWatch portal or call NutriCorp’s hotline at 1-800-NUTRI-911 for reimbursement. As investigations deepen, health officials predict more cases may emerge, urging vigilance. The FDA promises weekly updates, aiming to restore parental confidence and prevent recurrence in this critical lifeline for infants.

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