Two Compounded Tirzepatide Recalls for Lack of Sterility Assurance: Apothecary Pharma and Houston Rx
Last updated 2026-10-31 · Source: FDA enforcement reports (openFDA), recalls D-0036-2027 and D-0040-2027
Apothecary Pharma (NC) and Houston Rx (TX) recalled compounded tirzepatide vials for lack of sterility assurance. FDA classified both Class II (D-0036-2027, D-0040-2027).
What this means for your practice
This recall underscores the critical importance of supply chain vigilance for all healthcare practices, especially those administering injectable medications. For telehealth brands, medspas, and other clinics offering services that involve prescribing or dispensing medications like Tirzepatide, verifying the source and recall status of all pharmaceutical products is paramount. The 'lack of assurance of sterility' directly impacts patient safety, as non-sterile injectable products can lead to severe infections, sepsis, or other adverse health consequences. Practices must implement robust procedures for receiving, storing, and inventorying medications, including cross-referencing with FDA recall announcements. This situation serves as a critical reminder that even 'Rx only' products from seemingly reputable suppliers can be subject to significant quality issues. Ensuring that all medications administered or dispensed comply with FDA quality standards is not just a regulatory requirement but a fundamental aspect of patient care and risk management.
Two compounding firms have recalled compounded tirzepatide injections because they could not assure the products were sterile. Each firm started its own recall in late September 2026, and FDA then classified both as Class II recalls. They appeared in FDA's weekly enforcement reports on October 14 and October 21, 2026.
The two recalls
Apothecary Pharma LLC, Cary, North Carolina (D-0036-2027). The firm recalled Tirzepatide Injection, 18 mg/mL, in 4 mL sterile multi-dose vials (Rx only, NDC 85091-001-18). The enforcement report lists 22 vials across 22 lots numbered from AP-202622 to AP-202644 (AP-202626 is not among them), with beyond-use dates from October 7 to November 26, 2026. Apothecary Pharma started the recall on September 24, 2026 and notified customers by letter. FDA classified it on October 8, and it was reported on October 14. Distribution was nationwide within the United States.
Houston Rx LLC, Houston, Texas (D-0040-2027). The firm recalled Tirzepatide/Niacinamide injection, 20 mg/2 mg per mL, in 2 mL vials (40 mg per vial, Rx only). The report lists 64 vials from lot TZN-080326-20/2-2, beyond-use date December 1, 2026. Houston Rx started the recall on September 25, 2026 and notified customers by two or more methods (email, fax, letter, press release, telephone or visit). FDA classified it on October 13, and it was reported on October 21. Distribution was nationwide.
Both recalls are voluntary, firm-initiated recalls, and both were still listed as ongoing when this was written. The reason given for each is lack of assurance of sterility. Neither enforcement report describes the cause in more detail.
What a Class II recall means
FDA's recall rules (21 CFR 7.3) define Class II as a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA assigns the class after the firm starts the recall. The class describes the health risk; it does not mean FDA ordered the recall.
What this means for telehealth and weight-loss programs
- Check what you have dispensed. If your program sources tirzepatide from either firm, compare the lot numbers and beyond-use dates above with your dispensing records and any stock on hand, and follow the firm's recall instructions.
- Know who to tell. Patients who received an affected lot may still have vials at home. Decide in advance who contacts them, what they are told, and how adverse events are reported (FDA MedWatch).
- Ask your pharmacy partners about recalls. Your pharmacy agreement should say how, and how fast, the pharmacy tells you about a recall that touches your patients. A recall notice that stops at the pharmacy may not reach patients.
- Watch the weekly enforcement report. These two recalls appeared one week apart. A standing check of FDA's enforcement report for your products and pharmacies catches recalls that never get a press release.
Key facts
| Detail | Apothecary Pharma LLC | Houston Rx LLC |
|---|---|---|
| Recall number | D-0036-2027 | D-0040-2027 |
| Product | Tirzepatide Injection 18 mg/mL, 4 mL multi-dose vial | Tirzepatide/Niacinamide 20 mg/2 mg per mL, 2 mL vial |
| Quantity | 22 vials | 64 vials |
| Lots | 22 lots, AP-202622 to AP-202644 (no AP-202626) | TZN-080326-20/2-2 |
| Reason | Lack of assurance of sterility | Lack of assurance of sterility |
| Class | II | II |
| Recall started by the firm | September 24, 2026 | September 25, 2026 |
| FDA classified | October 8, 2026 | October 13, 2026 |
| Reported | October 14, 2026 | October 21, 2026 |
| Distribution | Nationwide | Nationwide |
Frequently asked questions
Did FDA order these recalls?
No. Both firms started their recalls voluntarily. FDA reviewed them and classified both as Class II.
What went wrong with the products?
The firms reported a lack of assurance of sterility. The enforcement reports do not give a more specific cause.
How do I find out whether my patients got an affected vial?
Compare the lot numbers in the table with your pharmacy's dispensing records, and ask the pharmacy that dispensed to your patients.
Sources: openFDA enforcement report, D-0036-2027 · openFDA enforcement report, D-0040-2027 · 21 CFR 7.3, recall definitions