FDA Investigation and Recall at a Major Infant Formula Plant (2022)
On February 17, 2022, the U.S. Food and Drug Administration (FDA) announced that it was investigating illnesses in infants who had been fed powdered infant formula made at one plant in Sturgis, Michigan, run by one of the largest U.S. formula manufacturers. The FDA warned consumers about certain powdered formula from the plant, the manufacturer recalled products under three of its formula brands, and production at the plant stopped. On May 16, 2022, a federal court entered a consent decree between the FDA and the manufacturer that sets the conditions for making formula there. The recall and shutdown, combined with pandemic-era strains on supply chains, are the events the FDA links to the infant formula shortage of 2022.
This page reports what the FDA’s own investigation and program pages say: what was announced and when, the illnesses under investigation, what Cronobacter is and how it is tracked, the recall, what the inspection and genetic testing found, the specialty formulas released case by case, how the recall led to a shortage, the consent decree, what the action does not do, its status as of October 18, 2026, and how it fits later FDA infant formula actions. No manufacturer, brand or product is named here; the bacterium itself is described on the site’s Bacteria page.
Table of Contents
- What the FDA Announced on February 17, 2022
- The Illnesses Under Investigation
- What Cronobacter Is and How It Is Tracked
- The Recall and the FDA Advisory
- What the Plant Inspection Found
- What the Genetic Testing Showed
- Specialty and Metabolic Formulas Released Case by Case
- From a Recall to a Nationwide Shortage
- The Consent Decree of May 16, 2022
- What the Action Does Not Do
- Dates and Legal Status as of October 18, 2026
- How It Fits Later FDA Infant Formula Actions
- Primary Documents
- Key Research Papers
- Connections
- Featured Videos
1. What the FDA Announced on February 17, 2022
The FDA’s investigation page, “FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022),” opens with the first announcement. On February 17, 2022, the FDA, together with the Centers for Disease Control and Prevention (CDC) and state and local partners, reported that it was investigating four consumer complaints of illness in infants, received between September 20 and December 18, 2021. All four infants were reported to have been fed powdered infant formula made at the Sturgis, Michigan plant. The complaints included three reports of Cronobacter sakazakii infection and one report of Salmonella Newport infection. All four infants were hospitalized, and the FDA wrote that Cronobacter “may have contributed to a death in one case.”
The FDA had already started an onsite inspection of the plant. Its findings to that date, in the agency’s words, included “several positive Cronobacter results from environmental samples taken by FDA, and adverse inspectional observations by FDA investigators.” The FDA added that a review of the firm’s internal records “also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.”
On that basis the FDA issued an advisory “to alert consumers to avoid purchasing or using certain powdered infant formula produced in the Sturgis, MI facility.” The investigation was carried out by the FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network, the agency’s team for foodborne illness outbreaks.
2. The Illnesses Under Investigation
The case list changed as the investigation went on. The FDA’s dated updates record these steps:
- February 28, 2022. The CDC announced one more Cronobacter sakazakii illness in an infant fed formula from the same plant, a case in which infection may have contributed to death. That infant had been fed a specialty formula meant for infants who benefit from a lower mineral intake, which was not part of the first recall. On the same day the manufacturer recalled the one lot involved. At that point the investigation included four Cronobacter infections and one Salmonella infection, all five hospitalized.
- March 9, 2022. The Salmonella Newport illness was removed from the investigation. The FDA explained that it had at first included every consumer complaint of illness linked to products from the plant, but “there is not enough information to definitively link this illness to powdered infant formula.” The CDC confirmed that this single illness was not linked to an outbreak.
- May 12, 2022. The CDC announced that its investigation was closed, with no additional cases identified.
The final case table on the FDA page reads:
- Total adverse events: 4
- Hospitalizations: 4
- Reported deaths: 2, with the note that “Cronobacter infection may have contributed to the cause of death for both patients”
- Illness onset dates: September 6, 2021 to January 4, 2022
- States: Minnesota (1), Ohio (2), Texas (1)
- Product distribution: nationwide and international
The FDA’s summary describes complaints and reports received from September 20, 2021 to February 24, 2022.
3. What Cronobacter Is and How It Is Tracked
Cronobacter sakazakii is a bacterium; the investigation concerned infections in infants who had been fed powdered formula. The FDA’s investigation page lists symptoms of Cronobacter infection in infants as “poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements,” and states that an infant with such symptoms needs a health care provider for immediate care.
The same page explains why cases are hard to count. In 2022 Cronobacter was “not nationally notifiable and not reportable except in one state,” meaning doctors and laboratories were not required to report cases to their health department. The FDA therefore relied on consumer complaints of illness sent to the agency and on health care providers telling the FDA directly about infants with Cronobacter infections. Because of that, the FDA wrote, whole genome sequencing was rarely performed on these bacteria, and “To date, no outbreaks of Cronobacter have been detected using WGS.”
Whole genome sequencing (WGS) is a laboratory method that reads the full genetic code of a bacterium, so that samples from patients and from a factory can be compared to see whether they are the same strain. When single cases are reported, the FDA page says, the agency reviews each complaint, samples products and starts inspections as appropriate, working with the CDC, which developed a detailed questionnaire for Cronobacter infections.
This changed after 2022. The FDA’s status update reports that the Council of State and Territorial Epidemiologists adopted a position on June 29, 2023 making Cronobacter a nationally notifiable disease, effective in 2024, a step the FDA says it supported.
4. The Recall and the FDA Advisory
The FDA’s update of February 20, 2022 records that on February 17 the manufacturer “initiated a voluntary recall of certain powdered infant formulas.” Products made at the plant were found across the United States and, the FDA said, were likely exported as well; Canadian health officials also issued a recall warning. A voluntary recall is one carried out by the company itself, here working with the FDA.
The recall covered powdered formulas sold under three of the manufacturer’s brands, plus, from February 28, one lot of the low-mineral specialty formula described above. On March 15, 2022 the FDA published a full list of the recalled products from the first and the expanded recall. Recalled containers could be identified by a code and expiration date printed on the bottom of the package. According to the firm, as reported by the FDA, recalled products for markets outside the U.S. went to more than 30 countries and locations.
The FDA’s statements to parents and caregivers on the investigation page include:
- that the agency was “advising consumers not to use” the recalled powdered formulas;
- that “The recalls do not include liquid formula products”;
- that parents and caregivers “should never dilute infant formula and should not make or feed homemade infant formula to infants,” and that consumers “should also avoid purchasing imported formula through online sales, as it has the potential to be counterfeit”;
- that families whose regular formula was unavailable could contact their child’s health care provider about changing feeding practices, and that families receiving formula through WIC (the Special Supplemental Nutrition Program for Women, Infants, and Children) could return recalled formula to the store for a refund and exchange.
These are the FDA’s own words, quoted as a record of what the agency said in 2022; decisions about feeding an individual infant belong with a clinician.
5. What the Plant Inspection Found
The FDA’s inspection of the plant ran from January 31 to March 18, 2022. The agency’s update of March 31, 2022 reports the sampling results:
- Five environmental subsamples from the plant were positive for Cronobacter sakazakii: four detected by the FDA and one detected through testing the firm itself started.
- Whole genome sequencing of those five positive environmental samples revealed five different strains of Cronobacter sakazakii.
- Product samples collected by the FDA at the plant were tested for Cronobacter and were negative.
At the end of the inspection the FDA issued a Form 483, the agency’s written list of inspectional observations, with four observations. On March 22, 2022 the FDA released the Form 483s from three inspections of the plant: September 16–24, 2019; September 20–24, 2021; and January 31 to March 18, 2022. The FDA listed among the important observations in the 2022 form that the firm:
- “did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment”; and
- “did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.”
The FDA added that inspectional observations “do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations,” and that it would take further action “if warranted” as it continued to evaluate the 2022 findings.
6. What the Genetic Testing Showed
The same March 31 update reports the CDC’s laboratory results. The CDC had completed testing of two clinical samples, meaning bacteria taken from patients, received in the investigation. Whole genome sequencing “did not find these samples from patients to be a genetic match to the multiple strains of Cronobacter found in the environmental samples” from the plant, or to any other clinical isolates in the database of the National Center for Biotechnology Information.
Put together with the inspection results, the FDA’s documents show two findings side by side: Cronobacter was present in the plant environment in five different strains, while the two patient samples that could be sequenced did not match any of them, and the FDA’s own product samples tested negative.
7. Specialty and Metabolic Formulas Released Case by Case
Some infants and other people depend on specialty and metabolic formulas, products for rare medical conditions that the FDA notes are not sold in ordinary retail stores and often require a prescription. The FDA’s investigation page reports that the manufacturer committed to enhanced testing of stored batches before deciding whether to release them, testing the FDA said would give “a greater chance to detect Cronobacter sakazakii, if present,” while noting that finished product testing “does not eliminate the risk of contamination.”
In the meantime, the FDA told the manufacturer it had no objection to releasing certain specialty and metabolic formulas from the plant, case by case, to people needing urgent, life-sustaining supplies. The agency gave its reasoning: it was “concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products,” and in those circumstances the benefit of access “may outweigh the potential risk of bacterial infection.”
The FDA also stated that the conditions it observed at the plant during the inspection “raise concerns that powdered infant formula produced at this facility prior to the FDA’s inspection carry a risk of contamination,” and it described the decision to use a released product as one for families to weigh together with their health care provider.
8. From a Recall to a Nationwide Shortage
The FDA’s program page on enforcement discretion describes the chain of events in one sentence: the voluntary recall in February 2022 “and subsequent voluntary cease in production at their Sturgis facility, combined with the overall strains on supply chains experienced during the COVID-19 pandemic, created concerns about the availability of certain types of infant formula.”
The investigation page records the FDA’s early response. On February 25, 2022 the FDA wrote that it understood “infant formula is the sole source of nutrition for many infants and is an essential product,” and that, as the recall began, it had intensified outreach to other infant formula manufacturers about their capacity. It also reported working with the manufacturer on production capacity at its other plants and on “safe resumption of production” at Sturgis, and partnering with the U.S. Department of Agriculture’s Food and Nutrition Service to monitor the recall’s effect on the WIC program.
On April 1, 2022 the FDA set up an Incident Management Group to work on supply chain and food safety issues; the FDA page notes that the work continued there once its outbreak team was no longer investigating. On May 24, 2022 the FDA announced that it would exercise enforcement discretion for specific infant formula products to increase supplies. That response, which included letting safe imported and domestic formulas onto U.S. shelves case by case, is reported on its own page, FDA Flexibilities to Ease the Infant Formula Shortage (2022). The FDA’s status update adds that during the crisis FDA staff worked daily with clinicians and hospitals on the supply of specialty formulas for infants with serious metabolic diseases.
9. The Consent Decree of May 16, 2022
The FDA’s update of May 17, 2022 reports that on May 16, 2022 “the U.S. District Court for the Western District of Michigan entered a consent decree of permanent injunction between FDA and” the manufacturer, “as well as three” of its principals. Under the decree, the FDA wrote, the manufacturer “will, among other things, take corrective actions following an FDA inspection of its Sturgis, Michigan facility.”
A consent decree is a court order whose terms both sides agree to. The FDA’s December 2023 status update describes what this one requires: the decree “requires” the manufacturer “to take the steps necessary to safely produce infant formula in close coordination with FDA and under our oversight of its manufacturing and food safety processes.”
The text of the decree itself and the Justice Department’s announcement were not among the documents read for this page, so its specific terms are not set out here. The three principals are individuals at the firm and are not named.
10. What the Action Does Not Do
- It did not cover liquid formula. The FDA states that “The recalls do not include liquid formula products.”
- It did not cover every formula maker. The advisory, recall and consent decree concern one manufacturer and its Sturgis plant. The consent decree binds that manufacturer; it sets no new rule for the formula industry.
- The inspection findings are not a final legal ruling. The FDA states that the Form 483 observations “do not constitute final FDA determinations” that the law was violated.
- It did not establish that the plant’s bacteria caused the illnesses. The two patient samples sequenced by the CDC did not match the strains found at the plant, and the FDA’s product samples tested negative.
- It did not end the supply of specialty formulas. Certain specialty and metabolic formulas from stored stock could still be released case by case for urgent needs.
11. Dates and Legal Status as of October 18, 2026
- September 20 to December 18, 2021: the FDA receives the first complaints of infant illness linked to formula from the plant.
- January 31, 2022: the FDA inspection of the plant begins.
- February 17, 2022: the FDA announces its investigation and consumer advisory; the manufacturer starts a voluntary recall.
- February 28, 2022: the recall is expanded to one lot of a specialty formula after a further Cronobacter case.
- March 9, 2022: the Salmonella case is removed from the investigation.
- March 18, 2022: the inspection ends with a Form 483 listing four observations; Form 483s from 2019, 2021 and 2022 are released on March 22.
- April 1, 2022: the FDA sets up an Incident Management Group for supply and safety issues.
- May 12, 2022: the CDC closes its investigation with no further cases.
- May 16, 2022: the federal court in the Western District of Michigan enters the consent decree of permanent injunction.
Status as of October 18, 2026: the investigation is closed; the consent decree was in force at the FDA’s last update read for this page. The FDA’s December 2023 status update (page current as of August 20, 2024) states that the FDA “continues to work with” the manufacturer under the consent decree. No later FDA document read for this page reports that the decree has ended. A consent decree is a court order rather than a regulation, so it does not appear in the Federal Register; a check of the Federal Register through October 18, 2026 for FDA documents on Cronobacter found only information-collection notices, none of which change this action. The date production resumed at the plant is not stated in the FDA documents read for this page and is not given here.
12. How It Fits Later FDA Infant Formula Actions
The recall became the starting point for a series of FDA infant formula actions described in the agency’s documents:
- March 2022. The FDA wrote that, once the immediate public health risk was minimized, it would conduct a programmatic review of its programs and policies on infant formula and special medical food complaints, illnesses and recalls. Its status update later refers to an evaluation of the agency’s infant formula response and to an evaluation of the FDA’s Human Foods Program by the Reagan-Udall Foundation, done at the FDA’s request.
- May to September 2022. Temporary enforcement discretion for safe imported and domestic formulas, followed by a transition plan (reported on its own page).
- November 2022. The FDA released a strategy to help prevent Cronobacter sakazakii illnesses linked to powdered infant formula, and charged the National Advisory Committee on Microbiological Criteria in Foods with questions on possible industry and public health interventions.
- 2022 law. The status update notes that the Food and Drug Omnibus Reform Act of 2022 (FDORA), passed by Congress, set a requirement for annual inspections of infant formula facilities and gave the FDA new authorities that it is using to establish an Office of Critical Foods, covering infant formula and medical foods.
- 2023. The FDA published an Immediate National Strategy in March 2023, sent a letter to the powdered formula industry, and issued warning letters to three infant formula manufacturers in August 2023. These steps are reported on FDA Steps to Tighten Infant Formula Safety (2023).
- 2025–2026. A later outbreak linked to powdered formula, of a different illness, is reported on Infant Botulism Outbreak Linked to Powdered Formula (2025).
For an earlier formula event outside the United States, see the site’s page on the 2003 soy formula thiamine-deficiency outbreak in Israel. Among other 2022 FDA food actions, the food traceability final rule and the frozen lentil crumbles illness investigation are reported on their own pages.
13. Primary Documents
- U.S. Food and Drug Administration. FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022). Outbreak investigation page with dated updates from February 17 to June 23, 2022; content current as of August 1, 2022 — fda.gov Cronobacter investigation page
- U.S. Food and Drug Administration. Status Update on FDA’s Infant Formula Response Activities. December 2023 update; content current as of August 20, 2024 — fda.gov infant formula status update
- U.S. Food and Drug Administration. Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies. Program page (background section); content current as of November 25, 2025 — fda.gov enforcement discretion page
The consent decree was entered by a federal court, not published as a rule, so there is no Federal Register docket for this action.
Key Research Papers
- Bowen AB, Braden CR (2006). Invasive Enterobacter sakazakii disease in infants. Emerging Infectious Diseases 12(8):1185-1189 — PubMed PMID: 16965695
- Friedemann M (2009). Epidemiology of invasive neonatal Cronobacter (Enterobacter sakazakii) infections. European Journal of Clinical Microbiology & Infectious Diseases 28(11):1297-1304 — PubMed PMID: 19662446
- Patrick ME, Mahon BE, Greene SA, Rounds J, Cronquist A, Wymore K, Boothe E, Lathrop S, Palmer A, Bowen A (2014). Incidence of Cronobacter spp. infections, United States, 2003-2009. Emerging Infectious Diseases 20(9):1520-1523 — PubMed PMID: 25148394
- Rounds J, Dale JL, Gross A, Tourdot LE, Snippes Vagnone P, Smith K, Medus C, Lynfield R (2026). Cronobacter Surveillance in Minnesota, United States, 2002-2024. Foodborne Pathogens and Disease 23(4):232-238 — PubMed PMID: 40095945
- Chauhan R, Tall BD, Gopinath G, Azmi W, Goel G (2023). Environmental risk factors associated with the survival, persistence, and thermal tolerance of Cronobacter sakazakii during the manufacture of powdered infant formula. Critical Reviews in Food Science and Nutrition 63(33):12224-12239 — PubMed PMID: 35838158
- Kalaitzandonakes M, Ellison B, Coppess J (2023). Coping with the 2022 infant formula shortage. Preventive Medicine Reports 32:102123 — PubMed PMID: 36798794
- Imboden A, Sobczak B, Kurilla NA (2023). Impact of the Infant Formula Shortage on Breastfeeding Rates. Journal of Pediatric Health Care 37(3):279-286 — PubMed PMID: 36528487
The first four papers describe invasive Cronobacter disease in infants and how often it has been recorded, including U.S. surveillance data. The fifth is a review of the factors that let Cronobacter sakazakii survive and persist during the manufacture of powdered formula. The last two study how families coped with the 2022 formula shortage and its effect on breastfeeding.
PubMed Topic Searches
Connections
- FDA Actions of 2022
- FDA and Regulation
- Infant Formula Shortage Flexibilities (2022)
- FDA Steps to Tighten Infant Formula Safety (2023)
- Infant Botulism Outbreak Linked to Powdered Formula (2025)
- The 2003 Soy Formula Thiamine-Deficiency Outbreak
- Bacteria
- Bacterial Illnesses
- Milk
- Food Traceability Final Rule (2022)
- Frozen Lentil Crumbles Illnesses (2022)