Texas Attorney General Ken Paxton sued Johnson & Johnson and Kenvue on October 28, 2025, alleging deceptive marketing of Tylenol to pregnant consumers and an improper transfer of product-related liabilities. Those are the State’s claims—not findings by a court that Tylenol causes autism or ADHD. The case sits amid a separate FDA safety-label process and federal litigation, neither of which establishes that the medicine causes those conditions.
What Texas alleges in its lawsuit
The Texas Attorney General’s petition asserts claims under state consumer-protection and fraudulent-transfer laws. It alleges that Johnson & Johnson and Kenvue deceptively marketed Tylenol to pregnant consumers despite evidence the State says raised concerns about possible neurological effects in children. It also alleges that liabilities associated with the product were transferred to Kenvue. The petition presents the plaintiff’s account of the dispute; a filing is not proof that its allegations are true.
In a November 2025 motion, the State sought temporary injunctive relief and repeated its legal theories. That motion is also an advocacy document, not an order granting relief.
Figures cited in the State’s pleading
The petition says approximately 65% of pregnant women take some form of acetaminophen during pregnancy and refers to at least 26 epidemiological studies. It also cites a 2020 cord-plasma study, reporting that its highest-exposure group had 3.62 times the risk of autism spectrum disorder (ASD) and 2.86 times the risk of ADHD compared with its lowest-exposure group. These are figures as described in Texas’s petition, including its account of one observational study—not court findings, a consensus count, or proof of cause and effect.
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What the FDA has said about acetaminophen and pregnancy
On September 22, 2025, the FDA said it had initiated a process to change the safety labeling for acetaminophen products, including Tylenol, based on evidence suggesting a possible association between use during pregnancy and autism or ADHD in children. The agency distinguished an association from causation: it said a causal relationship had not been established and that contrary studies existed.
FDA Commissioner Marty Makary said the agency was taking action to make parents and doctors aware of “a considerable body of evidence about potential risks associated with acetaminophen.” The FDA also noted that untreated high fever during pregnancy can itself pose risks. Its announcement described the start of a label-change process; it should not be read as proof of causation or as confirmation that a labeling change had been completed.
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How Kenvue responds
Kenvue, which makes Tylenol, disputes the claims. The company says current scientific evidence does not support a causal relationship between acetaminophen use during pregnancy and autism or ADHD. That is the company’s position; it does not resolve the scientific question or the Texas lawsuit.
What the federal appeals ruling did—and did not—decide
On July 13, 2026, the Second Circuit issued a ruling in separate federal acetaminophen litigation. It affirmed the exclusion of two plaintiffs’ experts, reversed the exclusion of three others, vacated the relevant judgments, and sent the matter back for further proceedings. The ruling addressed whether expert testimony could be considered. It expressly did not decide whether acetaminophen causes autism or ADHD, and it was not a ruling in Texas’s state case.
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- SWEET COATED TABLETS: Tylenol Extra Strength Coated pain relief pills are made with a sweet coating to help reduce aftertaste while providing fast-acting, safe and effective pain relief when used as directed
- EXTRA STRENGTH ACETAMINOPHEN FORMULA: Made with 500mg of acetaminophen, these extra-strength pain relief tablets help relieve symptoms caused by the common cold, toothache, headache, backache, and menstrual cramps
- HOW TO USE: Adults & children ages 12+, take two extra-strength pain relief tablets every six hours while symptoms last; Do not exceed six tablets in 24 hours unless directed by a doctor; Safe and effective when used as directed
- INCLUDES: 225-count bottle of Tylenol pain relief 500 mg Acetaminophen round coated tablets; #1 doctor recommended brand for pain relief & fever reduction; When used as directed Tylenol Extra Strength Pain Reliever offers an excellent safety profile.
What is known about the Texas case’s status
The Texas Attorney General announced the suit in October 2025, and the State later filed a motion seeking temporary relief. The available information here does not establish the latest docket status or a next scheduled action in Cause No. 2025-348. It therefore does not support saying the Texas case has been dismissed, decided, or set for trial.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What this means for consumers
The lawsuit is a legal challenge to the companies’ conduct, not a court determination that Tylenol causes autism or ADHD. The FDA has described a possible association while saying causation has not been established, and Kenvue disputes a causal link. Because the FDA also noted risks from untreated high fever in pregnancy, someone who is pregnant and has questions about fever or medication should discuss their circumstances with a healthcare professional rather than treating the lawsuit as individual medical advice.
Quick Recap
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- REGULAR STRENGTH: Pain Relief, Acetaminophen Tablets 325 mg are a regular strength remedy to help relieve minor aches, pains and fever.
- FOR ADULTS AND CHILDREN: A pain reliever and fever reducer for adults and children ages 6 years and over.
- GLUTEN FREE: This product is gluten free and contains no aspirin.
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