Federal inspectors once again flagged quality-control problems at Houston’s Empower Pharmacy during a November 2025 visit, according to newly posted federal records. The inspection found contamination in a drug-preparation area tied to a batch of testosterone that the company later pulled from the market, raising fresh questions about the pharmacy’s sterility controls. Empower operates large compounding facilities in northwest Houston that supply customized hormone and weight-loss medications to patients nationwide.
Newly published records spell out the concerns
According to the Houston Chronicle, the November inspection report reviewed by the paper shows investigators identified an earlier contamination event from August 2024. The Chronicle reports that Empower later carried out a voluntary recall in May 2025 of a testosterone lot of roughly 8,000 vials. The company told the paper that its own testing of the finished product did not show contamination and that it initiated the recall “out of an abundance of caution.”
Repeated warnings from the FDA
The latest inspection findings echo the problems outlined in U.S. Food and Drug Administration enforcement documents released earlier this year. In an April 2, 2025, warning letter to Empower’s larger Sam Houston Parkway facility, the agency wrote that “drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions” and cited failures in environmental monitoring and sterilization. That letter is posted on the FDA website.
The FDA issued a separate warning letter in April 2025 to Empower’s other Houston plant, documenting additional current good manufacturing practice, or CGMP, concerns at that location. Taken together, the letters laid out a pattern of sterility and quality issues that the agency said needed to be fixed.
What inspectors saw in November
The more recent inspection, now posted in FDA records and described by the Chronicle, says investigators observed staff failing to disinfect items such as scissors, gloves, and even a pen while those objects were present in drug-production areas. Inspectors also found that the company did not run media-fill stress tests under the most challenging conditions to demonstrate that its aseptic processes could reliably keep products sterile.
The Houston Chronicle reports that the FDA is likely to follow up to ensure Empower carries out corrective actions in response to the November findings.
Industry pressure and pending lawsuits
The renewed scrutiny of Empower comes at a time when compounding pharmacies across the country are under pressure for producing modified versions of popular GLP-1 weight-loss drugs. Drugmaker Eli Lilly has filed lawsuits this year against several companies and compounding pharmacies over copies of its tirzepatide products, and reporting by NPR and others has detailed that legal push and the wider regulatory debate over large-scale compounding of these medications.
What this means for patients and regulators
For patients receiving compounded injections or other customized medications, experts say the immediate step is basic but important: check product lot numbers and confirm with your provider or pharmacy that what you received is not part of any recall. That kind of double-check is especially relevant when questions are being raised about sterility in injectable products.
In its written correspondence with Empower, the FDA has warned that failures to address these violations “may result in legal action without further notice, including, without limitation, seizure and injunction,” language that underscores how seriously the agency views repeated sterility lapses at a pharmacy producing drugs for nationwide distribution.
Empower, for its part, says it has collected thousands of environmental samples across its facilities and that only a single sample showed contamination. The company also says it has been in communication with the FDA about its corrective actions. In the coming months, regulators will decide whether those fixes are sufficient or whether tougher enforcement steps are warranted.
