Kenvue Inc. (KVUE) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that Kenvue Inc. surfaced in its latest filing.

• In July 2021, Johnson & Johnson Consumer Inc. voluntarily recalled all lots of five Neutrogena® and Aveeno® aerosol sunscreen product lines after internal testing identified low levels of benzene.July 2021
• In September 2023, the FDA's Nonprescription Drugs Advisory Committee concluded that current data do not support the recommended dosage of orally administered phenylephrine as effective as a nasal decongestant, leading to putative class actions and shareholder derivative complaints against the Company.September 2023
• In November 2024, the FDA issued a proposed order to remove oral PE from the OTC monograph, with a final order pending.November 2024
• In September 2025, U.S. federal government officials made allegations regarding acetaminophen and the FDA initiated a label change process and issued a notice to physicians.September 2025
• In September 2025, a third party filed a citizen petition regarding safety-related labeling changes for OTC acetaminophen during pregnancy, and Kenvue Brands LLC responded requesting denial.September 2025
• In October 2025, the Company's subsidiary Kenvue Brands LLC was named in a case brought by the Texas Attorney General alleging that exposure to Tylenol® (acetaminophen) is associated with development of autism spectrum disorder and ADHD in children.October 2025
• In November 2025, the Attorney General of Texas sought to block the payment of Kenvue's regular quarterly dividend in a lawsuit regarding the safety of products containing acetaminophen.November 2025
• In November 2025, a second citizen petition was filed requesting the FDA update labeling of OTC acetaminophen products to reflect a potential risk of neurodevelopmental harm from early childhood exposure.November 2025
• In October 2021, Old JJCI implemented a corporate restructuring, establishing LTL Management LLC to assume sole responsibility for Talc-Related Liabilities.October 2021
• J&J retained Talc-Related Liabilities and agreed to indemnify Kenvue for these liabilities under the Separation Agreement; however, various parties have brought claims against Kenvue alleging liability for Talc-Related Liabilities.
• Kenvue has been named in claims and lawsuits related to talc-based baby powder in the United States and Canada, for which J&J has agreed to indemnify under the Talc-Related Liabilities.
• Johnson & Johnson Inc. has been named as a defendant in two proposed class actions and various personal injury actions in Canada related to Zantac and other ranitidine OTC medications.
• J&J granted a worldwide license under the Trademark Phase-Out License Agreement for certain J&J-retained intellectual property, including the 'Johnson & Johnson' name and signature.
• Kenvue relies on J&J for manufacturing Motrin®, Tylenol®, Zyrtec®, and other OTC products under the Transition Manufacturing Agreement for terms of varying duration after the Kenvue IPO.
• Kenvue relies on J&J for quality and regulatory services under the Transition Services Agreement for terms of varying duration after the Kenvue IPO.
• The Proposed Transaction with K-C is pending under the Merger Agreement, which restricts corporate transactions and other specified actions without K-C's consent until closing.
• Under the Merger Agreement, the exchange ratio is fixed at 0.14625 shares of K-C common stock per share of Kenvue common stock, plus $3.50 in cash per share.
• Certain shareholders of the companies have filed lawsuits against the companies and/or their boards in connection with the Proposed Transaction.
• The Merger Agreement requires approval from certain regulatory agencies before completing the Proposed Transaction.
• Completion of the Proposed Transaction is expected to trigger change-in-control provisions in certain agreements to which Kenvue or K-C is a party.
• Senior Notes, commercial paper program, Revolving Credit Facility, and finance lease liabilities are the specific financing arrangements.
• The Compensation & Human Capital Committee has granted, and expects to continue granting, equity-based awards under the Kenvue 2023 Plan.
• Kenvue is addressing contamination from historical operations at certain current or former properties and is involved in proceedings under the Comprehensive Environmental Response, Compensation, and Liability Act (Superfund) and comparable laws.
• Kenvue is subject to the California Consumer Privacy Act (as modified by the California Privacy Rights Act), the EU GDPR, the U.K. GDPR, and China's PIPL.