By Lew Kizer — 2026-10-27 — Health & Nutrition
The short answer
Apothecary Pharma LLC, a 503B outsourcing facility in Cary, North Carolina, voluntarily recalled compounded tirzepatide injection 18 mg/mL (22 vials, one in each of 22 lots) and one vial of NAD+ injection because of a lack of assurance of sterility. FDA classified the recall as Class II. No adverse events tied to the recall had been reported in coverage of the FDA Enforcement Report. This does not affect brand-name Zepbound or Mounjaro.
Key facts
- Firm: Apothecary Pharma LLC, Cary, N.C., registered with FDA as a 503B outsourcing facility.
- Tirzepatide injection 18 mg/mL, 4 mL multi-dose vial, NDC 85091-001-18: 22 vials in 22 lots (AP-202622 to AP-202625 and AP-202627 to AP-202644).
- NAD+ injection 200 mg/mL, 6 mL vial, NDC 85091-011-06: 1 vial, lot AP-202647.
- That is 23 vials in all, which explains the different counts in early news reports.
- Reason: lack of assurance of sterility. FDA classification: Class II. Status: ongoing, customers notified by letter.
- FDA sent the firm a warning letter on Dec. 1, 2025, after a May 2025 inspection found conditions that could compromise sterile production.
- Brand-name Zepbound and Mounjaro (Eli Lilly) are not part of this recall.
KINGSPORT, Tenn., Oct. 27, 2026 — A North Carolina compounding facility has recalled vials of compounded tirzepatide, the same active ingredient as Zepbound and Mounjaro, because it could not assure the medicine was sterile. The U.S. Food and Drug Administration classified the recall as Class II.
This article reports regulatory news and is not medical advice. If you use a compounded medicine, talk with your prescriber or pharmacist before you stop, start or change anything.
What was recalled
| Product | Strength and vial | NDC | Recalled | Lots |
|---|---|---|---|---|
| Tirzepatide injection | 18 mg/mL, 4 mL multi-dose | 85091-001-18 | 22 vials | AP-202622 to AP-202625; AP-202627 to AP-202644 |
| NAD+ injection | 200 mg/mL, 6 mL multi-dose | 85091-011-06 | 1 vial | AP-202647 |
Lot AP-202626 is not on the list. The recall was started by the firm, which notified customers by letter rather than a public news release. FDA lists it as ongoing in its Enforcement Report.
Early headlines disagreed on the count. Some said 22 vials, some 22 lots, some 23 vials. They are describing the same recall: 22 tirzepatide vials spread across 22 lots, plus one NAD+ vial.
Why sterility matters for an injection
Anything injected under the skin skips the body's first line of defense. "Lack of assurance of sterility" means the maker cannot document that the product was produced under sterile conditions. It does not by itself mean bacteria or mold was found in a vial.
This facility has been flagged before. In a Dec. 1, 2025 warning letter, FDA described a May 2025 inspection that found practices in its clean areas that could compromise sterility, including gowning and airflow problems, and labels on some tirzepatide and semaglutide products that lacked ingredient lists. Reporting on the recall does not say whether it is connected to those findings.
The bigger picture on compounded GLP-1s
FDA's consumer page on unapproved GLP-1 drugs reports 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide as of May 31, 2026, and says the true numbers are likely higher. Compounded drugs are not FDA-approved, so the agency does not review them for safety or effectiveness before they are sold.
Many people use them anyway, often because of cost. A preprint from USC and RAND researchers, not yet peer reviewed, estimates that about one in three U.S. adults using GLP-1 or GIP drugs got them outside conventional insurance and pharmacy channels.
What to check this week
- Look at your vial label. Check the maker, the NDC and the lot number against the table above.
- Call before you inject. If your vial matches, contact the pharmacy or prescriber that supplied it before using it.
- Follow FDA's handling advice for any multi-dose vial. FDA says to discard multi-dose vials 28 days after first use and to use a new sterile needle and syringe for every dose.
- Report problems. Side effects or quality issues can be reported to FDA MedWatch.
Where food fits
None of this changes what the medicine asks of your plate. A smaller appetite makes every bite count. Our GLP-1 meal planning guide covers protein-first eating on a reduced appetite, and the 7-day GLP-1 meal plan shows what a week can look like. If you are coming off a medicine, see GLP-1 maintenance meals.
“When you're on a GLP-1 medication, what you eat matters more, not less. You need high-protein, portion-controlled, nutrient-dense food — and you need to know it's safe. That's exactly what we do.” — Lew Kizer, Founder, SmashMeals
Commentary, not medical advice
The SmashMeals perspective
We cook for a lot of people on GLP-1 medicines, and plenty of them use compounded versions because the brand name is out of reach. We are not here to judge that. We are here to say: know where your vial came from, ask questions when something seems off, and let your prescriber steer the medicine. The food is the part we can help with. A smaller appetite still needs real protein and real meals, and you should never have to wonder what is in them.
Frequently asked questions
Which tirzepatide was recalled in October 2026?
Compounded tirzepatide injection 18 mg/mL in 4 mL multi-dose vials from Apothecary Pharma LLC of Cary, North Carolina, NDC 85091-001-18, lots AP-202622 through AP-202625 and AP-202627 through AP-202644. One vial of the firm's NAD+ injection, lot AP-202647, was also recalled.
Is Zepbound or Mounjaro recalled?
No. This recall covers compounded tirzepatide made by Apothecary Pharma, not Eli Lilly's FDA-approved Zepbound or Mounjaro.
Why did reports say 22 vials and others say 23?
Both are correct. The recall lists 22 tirzepatide vials, one in each of 22 lots, plus 1 NAD+ vial, for 23 vials total.
What does a Class II recall mean?
FDA uses Class II when use of a product may cause temporary or medically reversible health problems, or when the chance of serious harm is remote. 'Lack of assurance of sterility' means the firm cannot show the product was made sterile; it does not by itself mean contamination was found.
What should I do if I have a recalled vial?
Do not inject from it until you have talked with the pharmacy or prescriber who supplied it. They can tell you how to return it and what to use instead. Report any problems to FDA MedWatch.
Sources and credits
Follow the original sources for context and verification. A reference is not an endorsement of SmashMeals.
- FDA Enforcement Report, recall event 99952 (Apothecary Pharma LLC) (opens in a new tab)
U.S. Food and Drug Administration
Why it matters: The primary record of the recall: products, lots, classification and reason.
- Warning Letter: Apothecary Pharma, LLC, 717972 (Dec. 1, 2025) (opens in a new tab)
U.S. Food and Drug Administration
Why it matters: FDA's earlier findings about sterile production at the same facility.
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (opens in a new tab)
U.S. Food and Drug Administration
Why it matters: Adverse event counts for compounded GLP-1s and FDA's safety advice for patients.
- Apothecary Pharma recalls compounded tirzepatide and NAD+ vials over sterility concerns (opens in a new tab)
Managed Healthcare Executive
Why it matters: Detailed reporting of the Enforcement Report entries, including lot numbers.
- GLP-1/GIP Uptake, Indication, and Access Pathways Among US Adults in the Understanding America Study (preprint, Sept. 2, 2026) (opens in a new tab)
medRxiv (USC and RAND researchers)
Why it matters: Not yet peer reviewed. Estimates about a third of users get GLP-1s outside conventional channels.