Compounded tirzepatide was recalled. What has the FDA found?

Who this is for

This is for the physician or medical professional who owns a med spa or aesthetic practice that offers compounded weight-loss or wellness injections. It is also for the operations lead who orders those drugs from a compounding pharmacy and writes how the practice describes them to patients.

What we found

About one in eight US adults was taking a GLP-1 drug in late 2025. Some take a compounded version made by a pharmacy, which the FDA has not approved.^1,2

Apothecary Pharma, a North Carolina-based compounder, recalled 23 vials of injectable drugs because their sterility could not be assured. That means the vials cannot be counted on to be sterile. The recall began September 24, 2026, and was reported in October. Most of the vials were compounded tirzepatide, the active ingredient in Eli Lilly's Mounjaro and Zepbound, which are not affected. No illnesses had been linked to the recall when it was reported.^3,4,5

The FDA had warned the same facility in December 2025. Separately, the National Association of State Pharmacy Associations summarized FDA findings at Boothwyn, a different compounder, including two tirzepatide products at about 87% and 89% of labeled potency. The FDA has also reported overdoses from compounded semaglutide sold in varying concentrations. Its guidance calls it misleading to describe a compounded drug as generic or FDA-approved. That is because the FDA does not review compounded drugs for safety, effectiveness or quality before they are sold.^6,7,8,9

How many patients take GLP-1s, and how can pharmacies still compound them?

In a late-2025 poll of 1,350 US adults by KFF, a health policy research nonprofit, 18% had ever taken a GLP-1 drug. Another 12% said they were taking one now, to lose weight or to treat a chronic condition. Among adults 50 to 64, 22% were currently taking one.¹

Among adults diagnosed as obese or overweight who were not taking these drugs, 43% said they were at least somewhat interested in taking one to lose weight.¹ We looked at what this demand is doing to treatment menus in our GLP‑1 menu article.

BioPharma Dive, a trade publication, reported a Gallup survey in which 19% of Americans taking a GLP-1 for weight loss were on a compounded version that is not FDA-approved. Another 12% weren't sure whether theirs was a brand-name medication.²

The Alliance for Pharmacy Compounding (APC), the compounding industry's trade group, surveyed 16,500 compounders with the University of Mary Washington. Half of respondents (51%) increased staff or hours to meet GLP-1 demand. The median 503A pharmacy (a traditional compounding pharmacy that fills prescriptions for individual patients) serves 150 prescribers.¹⁰

Semaglutide injections had been in shortage since 2022 because of demand. In a February 21, 2025 update, the FDA said the manufacturer's stated supply and capacity can meet present and projected national demand, which ended the shortage.¹¹

Compounded GLP-1s remain allowed when the FDA-approved drug doesn't meet a patient's needs, for example when a person needs a lower dose or is allergic to an ingredient.²

Peptide rules are pending. AmSpa reported on October 16, 2026 that the FDA had sent a peptide "interim access policy" to the White House for review. The proposed policy could temporarily allow compounding pharmacies to make certain peptides, including the peptide BPC-157, while permanent rules are considered.¹²

What did Apothecary Pharma recall, and how serious is a Class II sterility recall in practice?

The American Med Spa Association (AmSpa), the trade group for med spas, published the details on October 22, 2026. The recall covers 22 vials of compounded tirzepatide and one vial of NAD+ injection.³

Each vial carries a national drug code (NDC), the product's federal identifier, and a lot number. The recalled tirzepatide (18 mg/mL, 4 mL multidose vials, NDC 85091-001-18) covers lots AP-202622 to AP-202625 and AP-202627 to AP-202644. The recalled NAD+ (200 mg/mL, 6 mL vial, NDC 85091-011-06) is lot AP-202647. A beyond-use date is the last date a compounded preparation is meant to be used. The recalled tirzepatide carries beyond-use dates from October 7 to November 26, 2026, so after November 26 no recalled vial should still be in use.³

WSOC-TV, a Charlotte television station citing USA Today, reported that the FDA raised the recall to Class II on October 10. Class II means patients could face "temporary or medically reversible adverse health consequences." The station adds that the risk of serious harm is small.¹³

NewsNation reported no illnesses had been linked to the recall at that time.⁵ Lohud, a Gannett newspaper, reports that anyone holding a matching vial should contact their prescriber before using it. A patient treated at a med spa should call the practice for more information.⁴

The FDA's enforcement page lists Apothecary Pharma as a 503B facility, which the FDA calls an outsourcing facility. The warning letter, issued December 1, 2025, cited serious deficiencies in sterile drug production, and the FDA said those deficiencies put patients at risk.^6,3

What did FDA inspections find in compounded GLP-1 batches?

A pharmacy trade summary of FDA findings covered Boothwyn, another compounding pharmacy, based in Kennett Square, Pennsylvania. The findings included a semaglutide product at about 80% of labeled potency and two tirzepatide products at about 87% and 89%.⁷

The same summary also cites deficiencies in Boothwyn's procedures for releasing products before final sterility testing was complete. Boothwyn began a voluntary recall on July 9, 2025.⁷

The FDA exists to protect consumers, but in its own words, "FDA does not approve or license any facility."⁹ The FDA's enforcement page lists warning letters and Form 483s by facility name. A Form 483 records an FDA investigator's observations at an inspection.⁶

State boards add their own sourcing rules. The Kansas State Board of Pharmacy requires the active ingredient to be pharmaceutical grade, not "research use," "investigational," "food" or "supplement" grade.¹⁴

Under the Kansas rule, the active ingredient must also come with a valid certificate of analysis naming the original manufacturer. It must also be sourced from an establishment registered with the FDA as a manufacturer of that drug substance. A certificate of analysis is the manufacturer's test report for a batch.¹⁴

More on weight-loss and wellness spending at med spas is in our medspa spending article.

How have some patients ended up taking 5 to 10 times their semaglutide dose?

The FDA has reported patients taking five to 10 times the intended dose. In those cases, providers had converted milligrams to units or milliliters incorrectly. The FDA also has reports of patients misreading syringes. These errors are more likely with compounded products, which patients often draw from a vial with a syringe. Wegovy comes in pens that deliver a preset dose.⁸

In its 2024 alert, the FDA said product concentrations "may vary depending on the compounder," which can lead to dosing errors. One provider meant to prescribe 0.25 milligrams (5 units) and wrote 25 units instead. The patient received five times the intended dose and had severe vomiting.⁸

Some patients were told to draw a 5-unit (0.05 milliliter) dose from a multidose vial with a U-100 insulin syringe. They drew 50 units instead.⁸

On our reading of that alert, a practice that changes pharmacies may receive a vial at a different concentration. The unit count for the same milligram dose can then change in a way that is not obvious to the typical patient on these medications.

A 2024 study in Clinical Toxicology counted 5,713 single-substance GLP-1 exposures reported to US poison centers from 2017 to 2022. The study classed 79.9% of them (4,551 cases) as therapeutic errors.¹⁵

Most cases involved women (71.3%). Serious medical outcomes occurred in 6.2% of cases, including one death.¹⁵

Novo Nordisk, the maker of Ozempic and Wegovy, cited FDA adverse event data in a 2024 letter. As of December 31, 2023, the FDA Adverse Event Reporting System (FAERS) held 352 cases associated with compounded semaglutide.¹⁶

Which GLP-1 claims has the FDA called misleading?

The FDA calls it false or misleading to describe a compounded drug as generic, as FDA-approved, or as clinically proven to match the approved drug. The same applies to saying the drug comes from an FDA-approved or FDA-licensed pharmacy, since no such approval or license exists.⁹

In March 2026, the FDA announced warnings to 30 telehealth companies over illegal marketing of compounded GLP-1s.¹⁷ Its guidance for those companies lists branding that implies the seller is the compounder. It also lists calling a compounded drug a generic version of an approved drug, or the same as one.⁹

In the FDA's words, "Generic drugs are approved by FDA prior to marketing, while a compounded drug is not approved by FDA." The list also covers claims that a compounded drug was evaluated for safety, effectiveness or quality before marketing.⁹

Our suggestions, based on these records: first, clinical teams should check stock against recalled lot numbers and log which patient got which lot. Then they can follow up with those patients as needed. Second, keep standard processes and clear records from the compounding pharmacy to the treatment room. Patients then get a consistent dose as rules, formulas and strengths change between GLP-1s. Finally, read the treatment page and consult script against the FDA's list of misleading claims, and consider other ways to build trust and visibility.

About this review

We read 17 sources in October 2026. They were five FDA pages, one Kansas State Board of Pharmacy document, four pages from three trade associations (AmSpa, APC and the National Association of State Pharmacy Associations), four news reports, one peer-reviewed study, one manufacturer letter and one KFF poll. No number here combines data points from two publishers.

The recall reports cover September and October 2026. The KFF poll covers 1,350 US adults surveyed in late 2025, and the poison center study covers 2017 to 2022. The FAERS count runs through December 31, 2023. The Gallup data points are as BioPharma Dive reported them. The peptide policy data point comes from AmSpa's news listing of October 16, 2026, and the Kansas rule applies in Kansas.

Fractional Aesthetics is a growth strategy practice for aesthetic medical businesses.