FDA warning letter: Apothecary Pharma, LLC
What the FDA told Apothecary Pharma, LLC in December 2025 about semaglutide and tirzepatide — and whether it has been resolved.
“Some of your facility’s drug products, such as Tirzepatide Injection 10 mg/mL and Semaglutide Injection 2.5 mg/mL, did not include the following information on the label: a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.”
What an FDA warning letter is
It is a letter. The FDA writes to a company to say which of its practices the agency believes break the law, and asks it to fix them. That is the whole mechanism: a written notice, published so anyone can read it.
It is the FDA’s position, not a court’s finding. The company can reply, and can disagree. The agency states in these letters that failing to address the problems may lead to further action such as seizure or an injunction — which tells you the letter itself is not yet either of those things.
A warning letter does not recall a product, suspend a licence or close a business. It does not mean that medicine already dispensed was unsafe. When the FDA is satisfied the problems are fixed, it publishes a closeout letter.
What it does tell you is that a regulator looked at this company and wanted something changed. The useful question is what — and the quoted passage above answers it more precisely than any summary can.
What the letter says
| Field | What the letter states | Source |
|---|---|---|
| Recipient | Apothecary Pharma, LLC | FDA warning letter |
| Issued | Dec 1, 2025 | FDA warning letter |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA warning letter |
| FDA reference | MARCS-CMS 717972 | FDA warning letter |
| Location | Cary, NC, United States | FDA warning letter |
| Subject | Compounding Pharmacy/Adulterated Drug Products | FDA warning letter |
| What it concerns | How the medicine was made | Read from the subject line |
| Medication named | Semaglutide and Tirzepatide | Letter text |
| Status | Open — no closeout letter published | FDA warning letter list |
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NADAC figures are pharmacy acquisition costs, not retail prices and not what you will pay. This content is educational and is not medical advice.