Johnson & Johnson (JNJ) Shares Plunge 1.05% to 2025 Low Amid FDA Warning, Talc Litigation

Johnson & Johnson (JNJ) shares fell 1.05% intraday on October 3, 2025, marking their lowest level since October 2025, with the 0.04% closing decline reflecting mounting regulatory and legal pressures. The selloff underscores investor concerns over two pivotal developments: an FDA warning letter targeting its vaccine subsidiary and a contentious bankruptcy-driven strategy to resolve talc-related litigation.

The U.S. Food and Drug Administration issued a formal warning to Janssen Vaccines, a key unit within JNJ’s pharmaceutical division, following a November 2024 inspection of its South Korean manufacturing facility. The agency highlighted lapses in quality control, including inadequate investigations into recurring vial stopper complaints and delayed reporting of product defects. These shortcomings raise questions about Janssen’s compliance with regulatory standards, potentially affecting vaccine safety perceptions and operational costs. The FDA has mandated a three-year retrospective review of quality issues and a revised remediation plan, with noncompliance risking further enforcement actions.

Simultaneously, JNJ faces legal turbulence as its subsidiary Red River Talc filed for Chapter 11 bankruptcy for the third time, seeking to finalize an $8 billion settlement for talc-related cancer lawsuits. The proposed “Texas two-step” strategy, designed to shield the parent company from liability, has drawn scrutiny following the Supreme Court’s June 2025 ruling on Purdue Pharma’s bankruptcy. Critics argue the maneuver circumvents accountability, while pending federal legislation could further complicate the process. A failed settlement risks exposing JNJ to protracted litigation, with individual verdicts potentially exceeding $100 million each, amplifying financial and reputational risks.

Investor sentiment remains volatile as these dual challenges test JNJ’s ability to balance regulatory compliance, legal strategy, and corporate reputation. The FDA’s demands for process overhauls could strain margins, while the talc litigation’s outcome hinges on judicial and legislative developments. For now, the stock’s trajectory reflects heightened sensitivity to both near-term operational hurdles and long-term liability uncertainties.