Empower Pharmacy Lawsuit: Eli Lilly, FDA Record, and Ruling

The Empower Pharmacy lawsuit brought by Eli Lilly and Company accuses the Houston-based compounder of unlawfully manufacturing and selling untested, unapproved copies of tirzepatide, the active ingredient in Mounjaro and Zepbound. The case is pending in the U.S. District Court for the Southern District of Texas before Judge Sim Lake, and in April 2026 the court dismissed Lilly’s federal trademark and Texas unfair competition claims while allowing unfair competition claims under other states’ laws to move forward.¹

What Eli Lilly Alleges

Lilly filed the current complaint on July 25, 2025, as case number 4:25-cv-03464, after voluntarily dismissing an earlier New Jersey action the same day.² The Texas complaint accuses Empower of “unlawfully manufacturing and selling untested, unapproved weight loss drugs on a large scale” and cites the Lanham Act, state consumer protection laws, and state deceptive trade practice laws.³

At the core of the case is Lilly’s claim that Empower misled consumers by advertising its compounded tirzepatide as safe, effective, and personalized when, according to the complaint, the products “create hazards for consumers.”⁴

How Empower Is Fighting Back

Empower has denied wrongdoing on every front. A company spokesperson said Empower “does not produce ‘copies’ of Eli Lilly’s drugs and does not violate any federal or state laws,” and framed the litigation as “not about safety” but “about control,” casting the suit as an effort by a major manufacturer to squeeze out affordable alternatives for patients who cannot access or afford brand-name medications.⁵ Empower also points to its status as an FDA-registered 503B outsourcing facility, which it says exempts its compounded products from needing separate FDA approval.

On September 29, 2025, Empower moved to dismiss the Texas complaint for failure to state a claim, calling the case an “anti-competitive move” and arguing that Lilly had not shown Empower’s advertising was “deceptive or harmful.”³

The April 2026 Ruling

Judge Lake ruled on the motion on April 29, 2026, and split the outcome. He dismissed Lilly’s federal Lanham Act trademark claims, finding that Lilly had not shown it lost sales or suffered “irreparable harm” from Empower’s allegedly false advertising. He also dismissed claims that Empower violated Texas unfair competition law.¹

The judge let unfair competition claims under the laws of other states proceed.⁶ Lilly called the decision the “third recent ruling that Lilly’s claims against compounders for unlawfully mass manufacturing and distributing unapproved drugs can proceed.” An Empower spokesperson described the dismissed trademark and Texas counts as the “central allegations” of the suit.¹ Under the court’s docket control order, dispositive motions in the surviving portion of the case are not due until September 2029.⁷

The FDA Record Behind the Allegations

Lilly’s claims land on top of a long regulatory record. The FDA has issued four warning letters to Empower over the past decade, with the two most recent both dated April 2, 2025.⁸

One April 2025 letter, addressed to Empower’s 503B outsourcing facility in Houston, cited violations of the Federal Food, Drug, and Cosmetic Act. The FDA found the site was producing sterile drugs under insanitary conditions and rendering them adulterated, pointing to inadequate environmental monitoring in the sterile processing area, deficient media fill testing, and failures to properly sterilize equipment that contacts injectable components.⁹ The second letter covered distribution of unapproved new drugs, misbranding, and failures in current good manufacturing practice.¹⁰ Both letters called Empower’s prior corrective actions “deficient” and said “repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”⁸

An August 2024 FDA inspection found that Empower had released a batch of Pyridoxine HCl (Vitamin B6) injection despite documented microbial contamination in the production area; the company recalled the product on September 5, 2024.¹⁰ A separate October 2024 inspection found the company had approved a batch of semaglutide mixed with vitamin B12 despite detected bacterial growth in the clean room.⁸

Since 2019, the FDA has received at least 17 reports of adverse reactions linked to Empower drugs, including seven hospitalizations. California Board of Pharmacy records reference at least 25 additional adverse events, including cases of cellulitis.⁸

State Enforcement Actions

At least a dozen states have brought enforcement actions against Empower over the past decade for violations of state pharmacy rules, including illegal compounding of commercially available drugs. Oklahoma, Idaho, Iowa, and Alabama have collectively imposed tens of thousands of dollars in fines.⁴

California has moved most aggressively. In 2022, the state Board of Pharmacy alleged Empower used ungraded or food-grade raw materials to produce sterile drugs, initially sought to revoke the company’s license, then stayed the revocation and placed Empower on four years of probation. In late 2025, the board filed a 49-page petition with more than 40 charges seeking to revoke that probation. The petition accused Empower of “dishonesty and deceit” for dispensing GLP-1 drugs to California patients after assuring regulators it would not, allegedly by shipping to Nevada where a prescriber collected and transported the drugs into California. The board also alleged Empower failed to disclose 50 product quality complaints and 10 adverse effect complaints discovered during a 2022 inspection, and that in one instance a hormone drug was dispensed at 10 times the prescribed concentration.¹¹ Wisconsin denied the company’s 503A pharmacy license application, and a 2022 Texas State Board of Pharmacy complaint remained pending as of reporting.

Why the Case Exists Now

The Lilly suit is one front in a broader push against compounders that kept making GLP-1 drugs after the FDA declared the shortages resolved: tirzepatide in December 2024 and semaglutide in February 2025. Federal law allows compounders to produce copies of commercially available drugs only while an FDA-recognized shortage exists. When the trade group Outsourcing Facilities Association sought preliminary injunctions to block the FDA’s end-of-shortage determinations, a federal judge in the Northern District of Texas denied the tirzepatide request on March 5, 2025, calling the FDA’s decision an “informal adjudication” that did not require formal rulemaking. A parallel semaglutide request was denied on April 24, 2025.¹²

Lilly and Novo Nordisk then opened aggressive private-litigation campaigns. Beyond Empower, Lilly sued Strive Pharmacy in Delaware and telehealth sellers including Fella Health, Willow Health, Henry Meds, and Mochi Health in the Northern District of California.¹³ Some of those cases have failed. A Delaware federal judge dismissed the Strive case in October 2025, noting compounded drugs can be “a godsend” for patients with allergies or unique needs; the Willow Health case was dismissed that September.¹⁴ Novo Nordisk announced on August 5, 2025, that it had filed 132 complaints in federal courts across 40 states targeting compounders and telehealth companies selling unapproved compounded semaglutide.¹⁵

Who Empower Is

Empower Pharmacy was founded in Houston in 2009 by Shaun Noorian and operates as both a 503A compounding pharmacy and an FDA-registered 503B outsourcing facility, serving providers and patients in all 50 states.¹⁶ The company dispenses roughly 70,000 prescriptions per week and generated $311 million in revenue during the first 10 months of 2024 according to the Houston Chronicle, with 94 percent coming from its 503A pharmacy, which operates under less rigorous safety standards than the 503B facility.¹⁷

Empower acquired a 503B manufacturing facility in East Windsor, New Jersey, in 2024, saying it could produce 50 million vials annually.¹⁸ By December 2025, the company had moved that site to a “standby state” and cut hundreds of staff.¹⁹ In June 2026, Noorian told the Houston Business Journal that Empower’s operations are “patient-centered and safety-first” and that he wants more regulatory clarity from the FDA.²⁰

1
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Houston Public Media. Eli Lilly Sues Houston-Based Compounding Pharmacy Over Alleged Knockoff Obesity, Diabetes Drugs
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