FDA sends a warning letter to a major compounder of GLP-1 drugs

FDA sent a warning letter to Empower Pharmacy, one of the largest compounders of GLP-1 drugs, about its compounded semaglutide and tirzepatide. A warning letter is not an order to stop. It lists violations FDA says it found and gives the company 15 working days to respond. The letter arrived alongside federal charges against two men accused of distributing counterfeit Ozempic, a Canadian recall over a dosing error, and new trial data on next-generation weight loss drugs. Together, these updates matter because they affect where you can safely and legally get a GLP-1 medication, and at what cost.

Empower Pharmacy is one of the largest compounders of semaglutide and tirzepatide, and many patients priced out of branded GLP-1 drugs have used its products. FDA's September 18 warning letter follows a November 2025 inspection of its Houston facility. FDA says products such as tirzepatide with niacinamide and semaglutide with cyanocobalamin appear to be essentially copies of approved drugs, made regularly and in large amounts, and it cites problems with how the pharmacy makes sterile products. The letter does not order the company to stop. It asks Empower to respond in writing within 15 working days, and FDA says that not fixing the violations may lead to legal action such as seizure or injunction. If you fill a prescription through Empower, nothing in the letter cancels it today, but I would suggest asking your prescriber now what your options would be if that supply changes.

Federal prosecutors in the Middle District of Florida and the Justice Department charged two men with conspiracy and smuggling in an alleged scheme to distribute counterfeit Ozempic, and FDA's criminal investigators assisted. According to the indictment, the men obtained counterfeit Ozempic from unauthorized sources in China between July 2023 and April 2024 and sold it to co-conspirators and distributors in the United States at deep discounts, in packaging meant to fool pharmacies and patients further down the chain. An indictment is an allegation, and both men are presumed innocent. Counterfeit products can contain the wrong ingredients, the wrong dose, or no active medication at all, which makes them a safety risk separate from the questions around compounded drugs. If you buy a GLP-1 medication from a source outside your regular pharmacy or clinic, it is reasonable to ask for proof that the product came from an authorized distributor.

Health Canada recalled one lot of Apo-Semaglutide 4 mg pens, lot 7000636A, because the pen may show 0.25 mg or 0.5 mg in the dose window and deliver that amount instead of the expected 1 mg dose. That means a patient could get less medication than intended. The recall applies in Canada, so patients in the United States are not directly affected, but it is a reminder that problems with GLP-1 pens are not limited to any one country or product. If you use an injection pen, checking for recall notices tied to your specific lot number may be worth doing periodically.

FDA has kept a docket open since 2015 on which bulk drug substances compounding pharmacies may use under section 503A of federal drug law. That same law also lets a compounder use an ingredient that is part of an FDA-approved drug, which is how semaglutide and tirzepatide are compounded, so this list is one piece of a larger set of rules. Empower's warning letter rests on a different rule, the one that limits regularly compounding drugs that are essentially copies of approved products. Patients considering a compounded GLP-1 drug may want to know that the compounding rules are still being settled, along with the status of any single pharmacy.

A phase 3 trial called TRIUMPH-2 tested retatrutide in adults who have both obesity and type 2 diabetes, and the results showed reductions in both body weight and blood sugar. Retatrutide works on three hormone receptors rather than the one or two targeted by current GLP-1 drugs, which is part of why researchers are watching it closely as a possible next step in treatment. A separate trial of the same drug also reported improvement in sleep apnea and knee pain among people with obesity. These results support, though do not guarantee, a path toward FDA approval, and patients interested in newer options may want to ask their prescriber how clinical trial timelines affect when a drug like this could become available.

If you currently get semaglutide or tirzepatide through a compounding pharmacy, the most useful step is to ask your pharmacy whether your medication comes from Empower, since this warning letter names only that company. It is also worth asking your prescriber about FDA-approved alternatives and how their cost compares. Beyond your own prescription, keeping an eye on where a GLP-1 product came from, and confirming it was dispensed by a licensed pharmacy, remains a reasonable precaution given the counterfeit charges described above. None of this requires an immediate decision, but it does call for a conversation with whoever manages your prescription before your next refill is due.

By Amanda Bonello