Empower Pharmacy Lawsuit, FDA Warning Letters, Eli Lilly Battle, $700M Legal Storm Hitting Compound Pharmacies
Eli Lilly filed lawsuits against Empower Pharmacy in April and July 2025, accusing the Houston-based compounding pharmacy of unlawfully manufacturing and selling untested weight loss drugs on a large scale. The FDA issued two warning letters to Empower in April 2025, citing sterility violations, contaminated products, and a September 2024 recall due to lack of sterility assurance. The Empower Pharmacy lawsuit has exploded into multiple legal battles worth potentially hundreds of millions.
The litigation targets Empower’s compounded versions of tirzepatide (sold under brand names Mounjaro and Zepbound), with pharmaceutical giants claiming these are unauthorized “knockoffs” that deceive consumers.
What Are the Latest Developments in the Empower Pharmacy Lawsuit?
Eli Lilly filed its second lawsuit against Empower on July 25, 2025, in the Southern District of Texas after voluntarily dismissing the New Jersey case filed in April 2025. This strategic shift may aim to consolidate claims and seek a more favorable venue in Texas.
The FDA sent two warning letters to Empower’s Texas facilities on April 2, 2025, following October 2024 inspections that uncovered critical violations. Inspectors found employees sanitizing gloves before performing personnel monitoring instead of immediately after aseptic filling, creating contamination risks for distributed lots.
A whistleblower lawsuit adds another layer: former supply chain director Brian Pray alleges Empower intentionally purchased adulterated and animal-grade ingredients to cut costs, ordering non-pharmaceutical materials “right after FDA audits”.
Eli Lilly Lawsuit: $700 Million Tirzepatide Battle
Eli Lilly’s April 2025 New Jersey lawsuit accuses Empower of selling “knockoff” versions of Mounjaro and Zepbound, including both injectable and orally disintegrating tablet (ODT) forms. The complaint states Empower is “essentially conducting a mass testing experiment on consumers” with its Tirzepatide ODT product.
Eli Lilly’s spokesperson said the FDA and federal courts have made clear that compounders “must cease production” of compounded tirzepatide. The lawsuits allege violations of state consumer protection laws, deceptive trade practice laws, and the Lanham Act.
Empower’s revenue jumped from $119 million in 2022 to $377 million in 2024, making it one of the fastest-growing mid-sized companies in Houston. The company now bills itself as the largest compounding pharmacy in the United States.
FDA Warning Letters: Sterility Failures and Contamination Risks
The FDA’s April 2025 warning letter confirms Empower recalled Pyridoxine HCL Injection Solution, 100mg/mL, lot 609763 on September 5, 2024, due to lack of sterility assurance. The company released this batch even after detecting positive microbial growth during environmental monitoring within the ISO 5 production area.
Critical FDA findings include:
- Discolored stains and embedded scratches inside ISO 5 LAFHs that may not be removable by cleaning alone
- Nonviable particulate sampling during April and October 2024 certifications that did not conform to ISO standard 14644-1:2015
- Employees failing to immediately perform personnel monitoring after aseptic filling, as required by company procedures
- Inadequate sterilization validation for stopper sorting bowls and insertion stations used in injectable drug production
The FDA stated it cannot fully evaluate some corrective actions due to lack of adequate supporting documentation, and Empower has not provided promised monitoring assessment forms.
What Legal Claims Does Empower Face?
The Empower Pharmacy lawsuit encompasses multiple legal fronts:
Eli Lilly Lawsuits (April & July 2025):
- Violation of state consumer protection and deceptive trade practice laws
- Lanham Act violations for false advertising and trademark infringement
- Claims of misleading consumers about drug safety and efficacy
FDA Regulatory Actions:
- Failure to ensure sterile compounding standards
- Producing drugs that violate the Federal Food, Drug, and Cosmetic Act
- Inadequate environmental monitoring and personnel procedures
Whistleblower Allegations:
- Intentionally purchasing adulterated and food/animal-grade ingredients
- Using suppliers with surreptitious Yahoo and Gmail accounts that were not properly vetted
Trade Secrets Lawsuit:
- Empower filed its own lawsuit in December 2024 accusing former executives of stealing trade secrets, financial data, and customer lists to set up a competing entity
Iowa Board of Pharmacy Violations
In 2024, the Iowa Board of Pharmacy filed new charges against Empower for failing to exercise professional judgment regarding prescription accuracy and compounding copies of federally approved drugs without clinically significant differences.
This followed a 2019 case where the board ordered Empower to permanently halt shipments of compounded human chorionic gonadotropin (HCG) into Iowa, placed the company’s license on probation for three years, and imposed a $25,000 civil penalty. A Polk County judge and the Iowa Court of Appeals upheld these sanctions in March 2023.
Novo Nordisk Joins the Fight
Novo Nordisk filed lawsuits on August 4, 2025, against 12 defendants including several pharmacies, marking a strategic shift as pharmacies had not been primary targets of Novo’s legal actions previously.
While Empower is not specifically named in the August wave, Novo Nordisk has filed 21 legal actions total against entities selling alleged “semaglutide” products, with testing revealing up to 24% impurities and unknown contaminants in some compounded products.
Drug Shortage Controversy
The FDA removed tirzepatide from the drug shortage list in October 2024, but this decision was remanded for reevaluation due to an Outsourcing Facilities Association lawsuit. In December 2024, the FDA again determined the shortage had been resolved, and removed semaglutide from the shortage list in February 2025.
These removals threaten compounding pharmacies’ legal ability to produce these medications. Under federal law, compounders can only make copies of brand-name drugs during FDA-declared shortages.
What Does Empower Say in Its Defense?
Empower’s spokesperson stated: “This lawsuit is not about safety. It’s about control. Empower Pharmacy has invested more into quality, compliance and regulatory infrastructure than any compounding pharmacy or outsourcing facility in history”.
The company maintains it does not produce “copies” of Eli Lilly’s drugs and does not violate federal or state laws. Empower argues it provides medications to patients who cannot afford name-brand treatments.
The pharmacy contends it adheres to state-level pharmacy board regulations and that FDA oversight over 503A pharmacies (which compound per prescription) is more limited compared to 503B outsourcing facilities.
What’s the Current Case Status?
Eli Lilly Texas Lawsuit:
- Filed July 25, 2025, in Southern District of Texas
- Active litigation ongoing
- Eli Lilly may leverage April 2025 FDA warning letters to argue Empower’s products are unsafe
FDA Enforcement:
- Two warning letters issued April 2, 2025, remain unresolved
- FDA recommends comprehensive assessment of operations, facility design, procedures, personnel, and processes
- No consent decree or injunction filed yet
Iowa Regulatory Action:
- New charges filed in 2024, building on 2019 violations
- Three-year probation from previous case still in effect
Internal Litigation:
- Empower’s trade secrets lawsuit against former executives filed in Federal Court in Houston (Case No. 4:23-cv-4123)
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What Do Recent Developments Mean for Patients?
Patients who received compounded weight loss drugs may face uncertainty about product safety and continued access. With the FDA declaring shortages resolved, the legal window for compounding these medications has closed.
Novo Nordisk testing revealed some compounded products contained no active ingredient, up to 24% impurities, or unknown contaminants. Patients using compounded versions should consult physicians about transitioning to FDA-approved alternatives.
What Happens Next?
Legal analysts predict the litigation could stifle the compounding pharmacy industry if pharmaceutical companies prevail, reducing patient options for personalized medications. If compounders successfully defend claims, it may reinforce their rights to operate within the regulatory framework.
The FDA may escalate enforcement if Empower fails to adequately address warning letter violations, potentially leading to consent decrees, injunctions, or criminal prosecution.
The Eli Lilly lawsuit discovery process will determine whether Empower truly tailors medications to individual patient needs or mass-produces copycat drugs. Court outcomes could establish precedent affecting thousands of compounding pharmacies nationwide.
Frequently Asked Questions
What are the latest developments in the Empower Pharmacy lawsuit?
Eli Lilly filed a second lawsuit against Empower on July 25, 2025, in the Southern District of Texas after dismissing the April 2025 New Jersey case. The FDA issued two warning letters in April 2025 citing sterility violations and a September 2024 product recall.
What is the most recent settlement status?
No settlement has been reached. Empower had until April 24, 2025, to respond to the initial Eli Lilly lawsuit but voluntarily dismissed that case before filing in Texas. All litigation remains active.
What are the current legal claims against Empower?
Eli Lilly alleges violations of state consumer protection laws, deceptive trade practice laws, and the Lanham Act. The FDA cites sterility failures, inadequate environmental monitoring, and production of adulterated drugs. Iowa regulators charge compounding copies of approved drugs without clinically significant differences.
Is Empower still operating?
Yes. Empower continues operations as one of the largest compounding pharmacies in the United States with approximately 1,000 employees. No court has ordered the company to cease operations.
What do recent FDA warning letters mean?
The April 2025 warning letters notify Empower that products may be adulterated and in violation of federal law. The FDA recommends comprehensive operational assessment and states that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drugs meet section 503A conditions.
Can patients still get compounded weight loss medications?
The legal landscape has changed significantly after the FDA declared shortages resolved for tirzepatide and semaglutide. Eli Lilly states that “anyone continuing to sell mass compounded tirzepatide, including by referring to it as ‘personalized,’ ‘tailored’ or something similar, is breaking the law and deceiving patients”.
What happens if Empower loses these lawsuits?
If pharmaceutical companies prevail, it could reduce patient access to compounded medications and potentially reshape the entire compounding pharmacy industry. Financial penalties could be substantial given the scale of Empower’s operations and revenue.
Disclaimer: This information is for educational purposes only and does not constitute legal advice. Case details, legal claims, settlement terms, and outcomes may change rapidly. Review current case filings independently and contact an attorney for specific questions about this case.
About the Author
Sarah Klein, JD, is a licensed attorney and legal content strategist with over 12 years of experience across civil, criminal, family, and regulatory law. At All About Lawyer, she covers a wide range of legal topics — from high-profile lawsuits and courtroom stories to state traffic laws and everyday legal questions — all with a focus on accuracy, clarity, and public understanding.
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