Abbott and DoJ settle federal lawsuit over contaminated infant formula

Company agrees to pay almost $385 million without admitting fault

September 14, 2026

The US Department of Justice (DoJ) and Abbott Laboratories have agreed to settle a federal lawsuit that was filed by the DoJ in November of 2025.

The lawsuit alleged that Abbott had “…caused government programs to purchase powder infant formula manufactured at the Sturgis facility despite the products’ failure to meet statutory, regulatory, and contractual requirements.”

In its November 2025 filing, the DoJ alleged that the company

failed to maintain its Sturgis, Michigan facility in a clean and sanitary condition
knowingly operated deteriorated major manufacturing equipment (spray dryers)
failed to validate key manufacturing processes
failed to maintain adequate testing records and failed to investigate positive results
avoided testing for the presence of microorganisms
failed to disclose to the FDA that the Sturgis facility had a recurring presence of microorganisms and failed to disclose positive test results to the FDA
falsely certified compliance with statutory, regulatory, and contractual requirements for WIC powder infant formula manufactured at the Sturgis facility

The backstory in a nutshell

On February 17, 2022, the FDA issued a warning to consumers not to use multiple Similac, Alimentum, or EleCare powdered infant formulas in response to reports of four illnesses among infants who had been fed the indicated products. Abbott initiated a voluntary recall of the products and suspended production pending the outcome of an FDA investigation.

The complaints spanned a period of time from September 6, 2021 to December 18, 2021, and were reported from Minnesota (1), Ohio (1) and Texas (2). Three of the infants were infected with Cronobacter sakazakii, and one with Salmonella Infantis. One of the infected infants died.

During its follow-up investigation of the company’s Sturgis manufacturing facility, the FDA uncovered multiple serious violations of good manufacturing practices, which were included in the DoJ’s list of allegations (see above).

In May 2022, the FDA and Abbott entered into a consent decree designed to allow Abbott to resume production under the close supervision of the FDA.

A tale of two news releases

The DoJ takes a victory lap

In its news release announcing the settlement agreement with Abbott, the DoJ took a victory lap while also summarizing some of the many maintenance and production flaws in general terms.

“Today’s settlement is a victory for American families and makes clear the safety of our children is not negotiable,” said Acting Deputy Attorney General Trent McCotter. “Abbott will pay a substantial sum to resolve serious allegations it violated federal health and safety requirements designed to protect babies. The Justice Department will act decisively against anyone who puts American families at risk and ensure misconduct carries serious consequences.”

“No company should be gambling on the health and safety of our Nation’s infants by allowing unsanitary conditions to persist at a facility manufacturing baby formula,” said Associate Attorney General Stanley E. Woodward, Jr. “The Department will hold accountable bad actors that knowingly misrepresent compliance with essential health and safety standards designed to protect American families.”

“It is critical that infant formula manufacturers adhere to regulatory and contractual requirements to ensure that the products they manufacture are safe for the babies who consume them,” said U.S. Attorney Timothy VerHey for the Western District of Michigan. “This settlement demonstrates our commitment to holding manufacturers accountable when the United States pays for noncompliant products.”

“Parents rely on companies like Abbott Laboratories to responsibly follow the rules and ensure their products – especially baby formula – are safe. USDA OIG remains vigilant against those that would compromise public health and safety by failing to comply with legal standards and put infants at risk,” said USDA Inspector General John Walk. “This behavior is inexcusable and will not be condoned.”

Abbott’s reply

Abbott’s news release disclaimed any finding of fault or liability and made no reference to the numerous violations documented during the FDA’s 2022 investigation and listed in the DoJ’s 2025 complaint.

Instead, while not denying the presence of Cronobacter sakazakii in its production environment, the company took pains to state that the strains of Cronobacter sakazakii found in the Sturgis production environment were different from the strains recovered from the sick infants, and that “no unopened, distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii.”

Abbott’s statement also underlined that other producers of powdered infant formula have reported “Cronobacter-related findings” in their manufacturing facilities, and that Cronobacter is found naturally in the environment.

The settlement

Most of the money from the settlement agreement ($348,700,868) will go to the federal government to resolve allegations under the False Claims Act. The remaining $36,298,172 will be distributed to certain States for claims settled by their State Medicaid and WIC programs.

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Happy Hens recalls eggs linked to Salmonella outbreak

September 11, 2026

Happy Hens has recalled three lots of in-shell organic eggs that may be contaminated with Salmonella.

The eggs have been linked to an outbreak of 23 Salmonella infections in San Diego County, California.

The following eggs, which were distributed to restaurants, grocery stores, and farmer’s markets in Southern California and the Central Coast and were available for sale directly at the farm in Ramona, California, have been included in the recall:

Happy Hens brand in-shell organic eggs, all grades and sizes:- (15-dozen cases (for foodservice), and 1-dozen carton, 18-count carton, 20-count flats, and 30-count flats (for consumer sale); Lot codes 223, 226, and 237; Sell by Sep 10, Sep 13, and Sep 24, respectively; Egg handler code CA-0677)

The California Department of Public Health has warned consumers not to eat the recalled eggs, and has published a list of retailers where the eggs were sold.

The backstory

On July 28, 2026, San Diego County announced that it was investigating 13 confirmed and probable cases of Salmonella infections, including 4 hospitalizations, linked to Ramona Family Naturals Market. Investigators believed the outbreak was connected to mayonnaise made with raw, unpasteurized eggs and used in chicken salads and sandwiches sold at the market. The Ramona market purchased its eggs locally.

On August 17, 2026, the County updated its information, revealing publicly for the first time that the raw eggs used to prepare the mayonnaise came from Happy Hens, a local poultry farm. By this time, the outbreak had grown to 21 cases, including 7 hospitalizations. Some of the outbreak cases appeared to be unrelated to the Ramona market that had prepared the mayonnaise cited in the initial report.

The same day on which the update was released, the FDA visited Happy Hens poultry farm to conduct what was described as a “routine inspection.” Their visit included collecting samples from the floor and perch rails/nest boxes of the hen houses where chicken excrement accumulates.

According to an update released by the County on September 4, 2026, two of the farm’s seven hen houses proved to be contaminated with Salmonella Enteritidis. The strain found in the hen houses matched the outbreak strain.

Happy Hens finally initiated its voluntary recall on September 8th, six weeks after the initial outbreak announcement.

What the public needs to know

The California Department of Public Health offers the following guidance:

Consumers should look for recalled eggs at home. If found, throw them away or return them to the place of purchase for a refund.
Businesses should not sell or serve any of the recalled eggs.
Consumers and businesses should wash and sanitize items and surfaces that may have come into contact with the recalled eggs using hot soapy water or a dishwasher.
Anyone finding these products for sale should call the CDPH Complaint Hotline at (800) 495-3232 or submit an electronic report to CDPH’s Food and Drug Branch.
Always handle and cook eggs properly to prevent illness from Salmonella:
- Cook eggs until both the yolk and white are firm.
- Cook dishes made with eggs to at least 160°F.
- Wash your hands and items that come in contact with raw eggs and eggshells with hot soapy water.
- Use only pasteurized eggs if they are to be consumed raw or undercooked.

If you thing you might have eaten any of the recalled eggs, and you begin to experience symptoms of a Salmonella infection, contact your healthcare provider.

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Alfalfa seeds implicated in outbreak of E. coli and Salmonella recalled

Seeds were supplied to wholesale consignees in 16 states and internationally

September 10, 2026

International Sprout Holdings Inc. has recalled 43,799 lbs of alfalfa seeds that may be contaminated with E. coli and Salmonella. The recall notice appeared in today’s FDA Enforcement Reports update.

The seeds are described as “Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506.” The recall extends to a single lot, identified as “ISS Lot # SAL2-24JB.”

International Sprout initiated the recall on August 23rd, notifying its customers by email.

Alfalfa seeds covered by this recall were supplied to wholesale consignees in California, Florida, Hawaii, Illinois, Massachusetts, Minnesota, Missouri, Montana, New York, Ohio, Oregon, Pennsylvania, Tennessee, South Carolina, Texas, Utah, Puerto Rico, Canada, Mexico, Tahiti, and Venezuela. Neither the wholesale consignees nor the ultimate downstream recipients of the alfalfa seeds were named.

The backstory

On August 21, 2026, the CDC and FDA announced that they were investigating a 15-state outbreak of 55 confirmed cases of Shiga toxin-producing E. coli (multiple serotypes include: O26:H11, O103:H25, O168:H8) and Salmonella Agona infections associated with consumption of alfalfa sprouts produced by Everything Sprouts, LLC of Minneapolis, MN.

Forty-six people were infected with one of the E. coli outbreak strains, 7 people were infected with Salmonella, and 2 people were infected with both Salmonella and E. coli.

Four of the victims were hospitalized.

Everything Sprouts announced a recall of three varieties of sprout products the following day and expanded the recall to include a fourth variety one week later.

But according to an investigation update issued on August 31st, sprouts produced by Everthing Sprouts did not account for all of the outbreak illnesses. The FDA’s traceback investigation identified at least one additional sprout grower who received the same batch of alfalfa seeds that had been supplied to Everything Sprouts.

The FDA recommended that the seed supplier voluntarily recall the suspect batch of seeds and contact its downstream customers to initiate recalls of sprouts grown from the those seeds.

The FDA did not name either the seed supplier (who we now know was International Sprout Holdings, Inc) or the second sprout grower, and there have been no other publically announced recalls of alfalfa sprouts in connection with this outbreak.

What to do?

This investigation is ongoing, and there has been no update from either the CDC or the FDA since August 31st.

The FDA offers the following recommendations to consumers and businesses:

Do not eat, sell, or serve recalled sprouts.
Check your refrigerators and freezers for recalled sprouts and throw them away or return the product to the place of purchase. If you froze a product without the original packaging and can’t tell if it’s part of the affected sprouts, throw it away.
Consumers, restaurants, retailers, and foodservice customers who purchased or received recalled sprouts, including wholesale products, should carefully clean and sanitize any surfaces or containers that they touched. Follow FDA’s safe handling and cleaning advice to reduce the risk of cross-contamination.
Retailers that received recalled sprouts and repackaged them for individual sale should not sell them and should remove the products from the market.
Consult your health care provider immediately if you ate recalled sprouts and have any symptoms that resemble an STEC or Salmonella infection.