Form 8-K

8-K — ABBOTT LABORATORIES

Accession: 0001104659-26-099247

Filed: 2026-08-20

Period: 2026-08-20

CIK: 0000001800

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2623675d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2623675d1_ex99-1.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

August 20, 2026

Date of Report (Date of earliest event reported)

ABBOTT LABORATORIES

(Exact name of registrant as specified in charter)

Illinois

1-2189

36-0698440

(State or other

Jurisdiction

(Commission File Number)

(IRS Employer

Incorporation)

Identification No.)

100 Abbott Park Road

Abbott Park, Illinois 60064-6400

(Address of principal executive offices)(Zip

Code)

Registrant’s telephone number, including

area code: (224) 667-6100

Check the appropriate box below if the Form 8-K filing

is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities

Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange

Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under

the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under

the Exchange Act (17 CFR 240.13e-4(c))

Securities Registered Pursuant to Section 12(b) of

the Act:

Title of Each Class

Trading

Symbol(s)

Name of Each Exchange

Which Registered

Common

Shares, Without Par Value

ABT

New York Stock Exchange

NYSE Texas

Indicate by check mark whether the registrant is an emerging

growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of

the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ¨

If an emerging

growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with

any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01

Regulation FD Disclosure.

On August 20, 2026, Abbott issued a press release announcing the settlement

of a portion of its litigation involving its specialty formulas for preterm infants. A copy of the press release is furnished hereto

as Exhibit 99.1 and is incorporated herein by reference.

The information contained in this Item 7.01, including Exhibit 99.1,

is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934,

as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration

statement or other filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference to

such filing.

Item 8.01

Other Events.

As previously reported in Abbott’s Annual Report on

Form 10-K for the fiscal year ended December 31, 2025 and its Quarterly Report on Form 10-Q for the quarterly period ended

June 30, 2026, Abbott is a defendant in numerous lawsuits alleging that preterm infants developed necrotizing enterocolitis

(“NEC”) as a result of being administered certain of Abbott’s preterm infant formula products. In a July

2024 Missouri state court trial, a jury awarded a plaintiff (“Gill”) $495 million in damages, which Abbott

appealed to the Missouri Court of Appeals in December 2024. The Missouri Court of Appeals affirmed the Gill verdict

in May 2026. On August 20, 2026, rather than continuing to appeal or paying approximately $600 million (representing the Gill

judgment plus accrued interest to date), Abbott entered into agreements to resolve the Gill lawsuit as well as NEC claims

asserted on behalf of approximately 2,000 additional infants for an aggregate amount of approximately $670 million. These agreements

are a compromise of disputed claims and not in any way an admission of liability. While Abbott remains confident in the safety of

these products and the science supporting them, the company believes these agreements are in its best long-term interest and

represent a constructive step toward substantially resolving the overall litigation.

Following these agreements, there are approximately 1,700 lawsuits

pending in federal and state courts involving claims on behalf of approximately 12,700 individual infants. That population includes

claims on behalf of individuals who named both Abbott and Mead Johnson as defendants without identifying which manufacturer’s formula

was administered, who were diagnosed with NEC before receiving any formula, who were never diagnosed with NEC, and who appear in multiple

lawsuits in different jurisdictions. Abbott continues to work to identify and eliminate such claims and others like them.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.

Exhibit

99.1 Press Release dated August 20, 2026 (furnished pursuant to Item 7.01).

104 Cover Page Interactive Data File (the cover page XBRL tags are embedded in the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities

Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly

authorized.

ABBOTT LABORATORIES

Date: August 20, 2026

By:

/s/ Philip P. Boudreau

Philip P. Boudreau

Executive Vice President, Finance and Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2623675d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Abbott reaches agreements to resolve

a portion of litigation involving its specialty formulas for preterm infants

· Agreements

will resolve the Gill case and claims involving approximately 2,000 other individuals

· Abbott

and the medical community stand by the safety of preterm infant formulas

· Regulators

and medical professionals recognize that these products are safe and necessary, and there

is no reliable scientific evidence that they cause necrotizing enterocolitis

ABBOTT PARK, Ill., Aug. 20, 2026 —

Abbott has reached agreements with three law firms to resolve the Gill case and claims involving approximately 2,000 other individuals

relating to the company’s specialty formulas for preterm infants.

In July 2024, a St. Louis jury

awarded the plaintiff in the Gill case $495 million in damages. Abbott appealed the verdict to the Missouri Court of Appeals

in December 2024, but the appeal was denied. Rather than continuing to appeal or paying approximately $600 million, representing the Gill judgment

plus accrued interest to date, Abbott entered into agreements to resolve the Gill case as well as necrotizing enterocolitis (NEC)

claims asserted on behalf of approximately 2,000 additional infants for an aggregate amount of approximately $670

million.

These agreements are a compromise of

disputed claims and not in any way an admission of liability. Abbott stands by the safety of these products and the essential role they

play in helping the medical community care for preterm infants. The Food and Drug Administration, National Institutes of Health, Centers

for Disease Control and Prevention, American Academy of Pediatrics, NEC Society, neonatologists and other medical professionals recognize

that these products are safe and necessary, and that there is no reliable scientific evidence that they cause NEC.

The agreements follow a series of favorable

rulings for preterm formula manufacturers in federal and state courts, including victories in all three federal Multidistrict Litigation

(MDL) bellwether cases. In July 2026, the U.S. Court of Appeals for the Seventh Circuit affirmed a pretrial judgment for Abbott in the

first federal MDL bellwether case involving the company's preterm infant formulas. In June 2026, the Illinois Appellate Court reversed

a $60 million verdict against Mead Johnson, finding that the trial court failed to properly apply the learned intermediary doctrine governing

a manufacturer's duty to warn, a defense relevant in a substantial number of cases. In March 2026, a Florida state court, applying the

learned intermediary doctrine, also dismissed claims involving preterm infant formula.

While Abbott remains confident in the

safety of these products and the science supporting them, the company believes these agreements are in its best long-term interest and

represent a constructive step toward substantially resolving the overall litigation.

Following these agreements, there are

roughly 1,700 lawsuits pending in federal and state courts involving claims on behalf of approximately 12,700 individual infants. That

population includes claims on behalf of individuals who named both Abbott and Mead Johnson without identifying which manufacturer's formula

was administered, individuals diagnosed with NEC before receiving any formula, individuals who were never diagnosed with NEC, and individuals

who appear in multiple lawsuits in different jurisdictions. Abbott continues to work to identify and eliminate such claims and others

like them.

Frequently Asked Questions

What is NEC?

Necrotizing enterocolitis, or NEC, is

an inflammatory intestinal disease, which typically affects premature infants. Challenges associated with prematurity – such

as an underdeveloped intestinal tract and immature immune system – can combine to lead to NEC, which explains why infants born

the most prematurely are at the highest risk of NEC.

Does preterm infant formula cause

NEC?

No. Numerous scientific papers and NEC

authorities have made clear that preterm infant formula does not cause NEC. Indeed, a 100-page report authored by a blue-ribbon

Working Group of 24 doctors and eight government officials organized by the Department of Health and Human Services explained that “[a]vailable

evidence supports the hypothesis that it is the absence of human milk – rather than the exposure to formula – that is associated

with an increase in the risk of NEC.”

Earlier this year, the AAP confirmed

that “[p]reterm infant formula is recommended when [mother’s own milk] is not available and [pasteurized donor human

milk] is either not available or the family declines use.” Dr. Mark Corkins, division chief of pediatric gastroenterology at the

University of Tennessee Health Science Center, said: “There is no evidence that the formulas cause NEC. That is why these court

cases make no sense to the folks who understand the actual science.”

What is preterm infant formula?

Preterm infant formulas are specialty

formulas that are designed to meet the unique nutritional needs of preterm and low-birth-weight infants, who need more calories and nutrients

than full-term infants to survive and thrive. Thus, these products differ from infant formulas for full-term infants that are sold in

stores directly to parents and caregivers. For decades, Abbott has researched, developed and produced these specialized nutrition

products, and today Abbott is one of only two companies in the U.S. providing these products. FDA regulates preterm infant formula, and

has not asked for changes or additions to the ingredients or label. Abbott complies with all applicable FDA regulations.

Is preterm infant formula part of

the standard of care?

Yes. The AAP has explained that

“[p]roviding special formula is a routine and necessary part of care of these preterm infants.” Likewise, the NEC Society

– a non-profit focused on eradicating NEC – explained that “[s]ometimes, formula is necessary and chosen by the baby’s

care team as the best available plan of care.” Preterm formula is especially important because mothers of premature infants may

have trouble expressing a sufficient supply of breast milk and donor human milk is not always available. In these situations, preterm

infant formula is a critical option.

In a brief filed on Aug. 7, 2026, to

the U.S. Supreme Court, the AAP, North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, National Association

of Pediatric Nurse Practitioners, Perinatal Research Society, Children’s Hospitals Neonatal Consortium, and March of Dimes wrote:

“Preterm infant formula is an indispensable component of neonatal medicine” and that “[t]he medical community universally

regards preterm formula as an essential, life-saving component of neonatal care.”

What have federal health authorities

and the medical community said about preterm infant formula?

The FDA, CDC and NIH, the AAP, and

the NEC Society agree that preterm infant formulas are a vital necessity in caring for premature infants and that feeding decisions should

be made in neonatal intensive care units (NICUs), not in courtrooms.

In October 2024, the FDA, CDC

and NIH said: “There is no conclusive evidence that preterm infant formula causes NEC.” Instead, “[a]vailable

evidence supports the hypothesis that it is the absence of human milk – rather than the exposure to formula – that is

associated with an increase in the risk of NEC.” These groups also said: “These formulas can be critical

for premature infants for whom parental or donor milk is not an option, or where a supplement to parental or donor milk is necessary

for the health of the infant.”

In September 2024, the American Academy

of Pediatrics said: “Specialty formulas and fortifiers provide an essential source of nutrition for premature infants. While

breastmilk is preferred, it does not eliminate the risk of NEC, and there is not always enough supply from a parent or donors.”

In July 2024, the American Academy

of Pediatrics said: “Courtrooms are not the best place to determine clinical recommendations for the care of infants. Feeding

decisions should be made by clinicians and families. These need to be individualized in the context of human milk availability, specific

patient needs, and individual family preferences.”

In July 2024, the NEC Society said:

“Feeding decisions should be made in the NICU, not in courtrooms.”

In April 2024, the NEC Society said:

“In the ICU, feeding decisions are medical decisions. It is imperative for medical decisions to be made by those who practice medicine

in partnership with patient-families. The medical team, in collaboration with patient-families, should decide how babies are fed in the

ICU. These medical feeding decisions aim to protect against NEC while providing optimal nutrition for discharge and long-term health

outcomes. Neonatal feeding decisions should be made at patients’ bedsides, not in courtrooms.”

Why does access to preterm infant

formula matter?

About 1 in every 10 infants born in

the U.S. is premature, per the CDC. But per the AAP: “there is not always enough [human milk] supply from a parent or donors”

for premature infants. As Judge Rebecca R. Pallmeyer, the judge in the federal MDL has recognized, “[t]his means that cow’s-milk-based

formulas, including [Similac Special Care 24], will remain essential products until the production of human-milk formula is sufficient

to eliminate any risk of shortfalls in all NICUs nationwide.” And “[f]ormula is designed to serve as a replacement whenever

donor milk or mother’s milk is unavailable, so the product’s utility is categorical, not marginal.” To use the

Court’s analogy, it is a “lifeboat” product.

Is the medical community concerned

about continued access to preterm infant formula?

Yes. As the AAP has said: “Feeding

decisions should be made by clinicians and families,” not litigants. When these decisions are taken from clinicians, physicians,

medical organizations and policymakers have expressed concern about continued access to preterm infant nutrition products.

These groups have warned of potential impact on availability if manufacturers cannot continue supplying them given the threat of unending

litigation.

In a brief filed on Aug. 7, 2026, to

the U.S. Supreme Court, the AAP, North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, National Association

of Pediatric Nurse Practitioners, Perinatal Research Society, Children’s Hospitals Neonatal Consortium, and March of Dimes wrote:

“The substantial verdicts already entered in other cases, together with the thousands of similar claims now pending, pose a grave

threat to the preterm formula supply. Should that supply diminish or be withdrawn, neonatologists and pediatric clinicians would lose

an essential instrument of care and with foreseeable consequences: increased infant mortality, impaired neurological development, and

permanent degradation of the standard of care for the Nation’s most vulnerable patients.”

What is the learned intermediary

doctrine?

In both Watson v. Mead Johnson

(Ill. App. Ct. 2026) and Ennix v. Abbott (Fla. Cir. Ct. 2026), courts held that the learned intermediary doctrine applies to preterm

formula used in the NICU. That doctrine provides that a manufacturer's duty is to communicate to doctors, not directly to the patient,

because it recognizes that doctors – not manufacturers – are in the best position to evaluate risks and benefits and advise

parents accordingly.

About Abbott:

Abbott is a global healthcare leader

that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare,

with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues

serve people in more than 160 countries.

Connect with us at www.abbott.com, and

on LinkedIn, Facebook, Instagram, X and YouTube.

Abbott Media:

Scott Stoffel, (224) 668-5201

Abbott Financial:

Michael Comilla, (224) 668-1872

# # #

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