Empower Pharmacy Lawsuit: Eli Lilly, FDA, and Whistleblower Claims

The Empower Pharmacy lawsuit filed by Eli Lilly accuses the Houston-based compounder of illegally manufacturing and selling knockoff versions of tirzepatide, the active ingredient in Mounjaro and Zepbound, and it is only one front in a much wider legal and regulatory storm around the company. Empower is also facing multiple FDA warning letters over insanitary manufacturing conditions, a California Board of Pharmacy petition to revoke its probation, and whistleblower countersuits from two former executives who claim the company cut corners on ingredients and sterility.

What Eli Lilly Is Suing Empower Over

In April 2025, Eli Lilly sued Empower Clinic Services, LLC and its affiliates, alleging the pharmacy was unlawfully manufacturing and selling compounded tirzepatide.¹ Two Empower products sit at the center of the complaint: a tirzepatide orally disintegrating tablet and a tirzepatide/niacinamide injection. Neither had been approved by the FDA.²

Lilly claims Empower made false statements about the safety, effectiveness, and “personalized” nature of its compounded tirzepatide and misrepresented its compliance with state and federal law.³ The claims are brought under the federal Lanham Act, which governs false advertising, along with several state consumer protection and deceptive trade practice laws.² Lilly is asking for an injunction to stop Empower from selling the products, arguing the pharmacy “creates hazards for consumers” and damages Lilly’s brand.

Empower has pushed back publicly, saying the lawsuit targets “healthcare companies like Empower who prioritize personalized, affordable care over profit,” and it continued listing compounded tirzepatide on its website.³

Where the Case Stands Now

Lilly originally filed in the District of New Jersey, voluntarily dismissed that case on July 25, 2025, and refiled the same day in the Southern District of Texas.⁴

On April 29, 2026, U.S. District Judge Sim Lake partially dismissed Lilly’s case. The judge threw out Lilly’s federal trademark claims, finding that the company had not shown lost sales or “irreparable harm” from Empower’s alleged false advertising, and dismissed claims under Texas unfair competition law.⁵ What survives are Lilly’s allegations that Empower violated unfair competition laws in states other than Texas.

Both sides claimed the ruling as a win. Lilly called it the “third recent ruling that Lilly’s claims against compounders for unlawfully mass manufacturing and distributing unapproved drugs can proceed.” An Empower spokesperson said the ruling struck down the “central allegations” of the lawsuit.⁵ The surviving state claims remain active in the Southern District of Texas.

What the FDA Has Found at Empower’s Facilities

The Lilly lawsuit landed on top of years of FDA scrutiny. Empower has received four warning letters and one untitled letter from the agency since 2017, along with repeated inspection findings dating back to 2013.⁶

On April 2, 2025, the FDA issued two warning letters to Empower on the same day. One letter, based on a September–October 2024 inspection, cited the pharmacy for producing injectable drugs under “insanitary conditions.” Inspectors described failures to properly sterilize equipment, inadequate environmental monitoring in cleanrooms, and deficient media fill testing, the process used to verify that sterile manufacturing procedures actually keep drugs sterile.⁷ The second letter, from an August 2024 inspection, flagged microbial contamination in aseptic processing areas, failure to investigate batch discrepancies, marketing of unapproved new drugs, and misbranding of products that lacked adequate labeling for adverse event reporting and dosage.⁸

Some of the findings were repeats. The FDA noted recurring failures in environmental monitoring and sterile-area maintenance flagged at prior inspections and a May 2023 regulatory meeting.⁸ Earlier 2022 and 2023 inspections found Empower distributing injectable products made with ingredients labeled “not for drug use,” “food additive,” or “food grade.”⁶ In September 2024, Empower recalled a batch of pyridoxine HCl (vitamin B6) injection after microbial contamination was detected in the production room. In May 2025, the company recalled roughly 8,000 vials of testosterone, which it described as voluntary and taken “out of an abundance of caution.”⁹

Empower disputes parts of the FDA’s account. The company said the August 2024 contamination was outside the “primarily filling area,” that finished products showed no signs of contamination, and that it has collected more than 5,000 samples across preparation areas with only one showing contamination.⁹

The Whistleblower Claims From Former Executives

Two former Empower executives have made allegations from inside the company. Samuel Pray, a former supply chain director who worked at the pharmacy from 2022 to August 2024, filed a countersuit in late January 2025 after Empower sued him for allegedly stealing company secrets and violating a non-compete.³

Pray alleges that CEO Shaun Noorian instructed employees to purchase food-grade or animal-grade active pharmaceutical ingredients to cut costs, and directed that those non-pharmaceutical-grade ingredients be ordered right after FDA inspections on the reasoning that the agency was unlikely to return anytime soon.⁶ He also claims Empower sourced ingredients through “surreptitious Gmail and Yahoo accounts” posing as middlemen, failed to verify whether suppliers were FDA-registered, and used active pharmaceutical ingredients that had failed quality control tests.³

On the GLP-1 side, Pray alleges Empower used “salt forms” of semaglutide to compound obesity drugs despite FDA warnings issued as early as 2023 that salt forms contain different active ingredients than the FDA-approved base form. A separate countersuit filed in April 2025 by former general counsel Matthew Ludowig, represented by the same attorney, alleges that Empower illegally produced impure GLP-1 drugs.³

Empower called Pray’s allegations “wholly unfounded in law and fact.” Chief operating officer Jonathan Abrarpour acknowledged in a court filing that Pray raised concerns about supplier qualifications “on a couple of occasions” but said those concerns were “appropriately received” and that Pray was never punished for raising them.⁶ The trade-secrets case Empower filed against Pray and co-defendants Revive RX, PSW Group, and Striker Pharmacy remains active, with appellate proceedings underway as of mid-2026.¹⁰

California’s Move to Revoke Empower’s Probation

State regulators have brought their own actions. In 2019, the California State Board of Pharmacy found that Empower had distributed over 1,000 “adulterated” vitamin C injectables.⁶ The board moved to revoke the pharmacy’s California licenses in 2022, then stayed that revocation under a four-year probationary period effective January 2023. Two California licenses were placed on probation and two others were fully revoked.¹¹

In November 2025, the board moved to revoke the probation entirely. A 49-page petition laid out more than 40 new charges, including allegations that Empower distributed GLP-1 drugs in California after agreeing not to, shipped drugs to Nevada for retrieval and transport back into California, and engaged in “dishonesty and deceit.” Investigators identified 938 previously undisclosed complaints from 2022 alone, including 50 related to product quality and 10 related to adverse effects. More than two dozen patients reported illnesses or side effects after taking Empower drugs between 2022 and 2025.¹² Iowa and Oklahoma have also penalized the pharmacy for regulatory violations.⁶

Why the Shortage Rule Matters

Much of the legal fight turns on one question: whether tirzepatide and semaglutide are in shortage. Under federal law, compounding pharmacies registered as 503B outsourcing facilities generally cannot produce drugs that are “essentially copies” of FDA-approved products unless those products are on the FDA’s drug shortage list.¹³

The FDA declared the tirzepatide shortage resolved on December 19, 2024, and the semaglutide shortage resolved on February 21, 2025. Temporary enforcement discretion for 503B outsourcing facilities closed on March 19, 2025, for tirzepatide and May 22, 2025, for semaglutide.¹⁴ The Outsourcing Facilities Association challenged those determinations in the Northern District of Texas, but the court denied preliminary injunctions on March 5, 2025, for tirzepatide and April 24, 2025, for semaglutide, letting the deadlines stand.¹³ The tirzepatide ruling is on interlocutory appeal at the Fifth Circuit.¹⁵

On April 30, 2026, the FDA went further, proposing to exclude semaglutide, tirzepatide, and liraglutide from the “503B bulks list” entirely, finding “no clinical need for outsourcing facilities to compound these drugs from bulk substances.” Public comment is open through June 29, 2026.¹⁶ If finalized, the proposal would further narrow the legal basis for compounding these drugs.

How the Pressure Is Affecting Empower

The combined weight of the litigation and regulatory actions has begun to show up in Empower’s operations. In December 2025, the company halted operations at its East Windsor, New Jersey facility, a 503B outsourcing facility it had acquired in 2024, and laid off staff. Empower said the site would be kept in “standby” mode while activities shifted to its Houston campuses.¹⁷ The company framed the move as a way “to respond to and stay ahead of industry-wide developments,” including the growth of GLP-1 drugs and rising quality expectations.⁹

The Houston facilities are still running, and Empower maintains that its operations meet regulatory standards. As of mid-2026, the surviving state unfair competition claims in Lilly’s lawsuit remain live in the Southern District of Texas, the California Board of Pharmacy’s petition to revoke Empower’s probation is pending, and the FDA’s proposal to exclude GLP-1 ingredients from the 503B bulks list is still in the comment period.¹⁶

1
CNBC. Eli Lilly Sues Strive and Empower Over Compounded Tirzepatide
2
Partnership for Safe Medicines. Eli Lilly v. Empower Complaint
3
Endpoints News. Pharmacy Empower Allegedly Used Low-Quality Ingredients, Skirted Rules
4
Buchanan Ingersoll & Rooney. Major Update on GLP-1 Litigation Involving Compounding Pharmacies
5
Houston Chronicle. GLP-1 Lawsuit Empower Pharmacy Eli Lilly
6
Houston Chronicle. Empower Pharmacy Compounded Drugs FDA
7
FDA. Empower Clinic Services Warning Letter 700964
8
FDA. Empower Clinic Services Warning Letter 700962
9
Houston Chronicle. Houston’s Empower Pharmacy Repeat Quality Issues
10
Trellis Law. Empower Clinic Services v. Pray, Samuel, et al.
11
California State Board of Pharmacy. Disciplinary Actions January-March 2023
12
Houston Chronicle. Houston Empower Pharmacy Charged New Violations
13
FDA. FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
14
Drug Topics. GLP-1 No Longer on FDA’s Drug Shortage List
15
Foley & Lardner. Compounded GLP-1 Drugs: Texas Judge Denies PI Motion
16
FDA. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide From 503B Bulks List
17
Endpoints News. Empower Pharmacy Cut Hundreds of Staff, Stopped New Jersey Operations