Apothecary Pharma Recalls Compounded Tirzepatide Nationwide Over a Lack of Assurance of Sterility

A compounded version of a drug that reaches many patients through telehealth weight-loss programs is the subject of a nationwide safety recall. Apothecary Pharma, LLC, an FDA registered 503B outsourcing facility in Cary, North Carolina, is voluntarily recalling compounded tirzepatide injection, along with one vial of a compounded NAD+ injection, over a lack of assurance of sterility. Because compounded tirzepatide is frequently prescribed and shipped through online weight-loss platforms and clinics, the recall is relevant to a group of patients who may not know which pharmacy prepared their medication.

What was recalled

The recall covers compounded tirzepatide injection made by Apothecary Pharma, LLC, a facility registered with the FDA as a 503B outsourcing facility. According to the FDA's Enforcement Report, the action covers 22 vials of Tirzepatide Injection, 18 mg/mL, in 4 mL sterile multi-dose vials (NDC 85091-001-18), spanning lots AP-202622 through AP-202644 with beyond-use dates running from October into November 2026. A companion entry covers one vial of Apothecary NAD+ Injection, 200 mg/mL, in a 6 mL sterile multi-dose vial (NDC 85091-011-06). The recall is described as voluntary and nationwide, and the firm initiated it on September 24, 2026.

Tirzepatide is the active ingredient in Eli Lilly's branded products Mounjaro (for type 2 diabetes) and Zepbound (for weight management). NAD+ (nicotinamide adenine dinucleotide) is an injectable marketed in wellness and longevity settings. Compounded versions of both are not FDA approved products; they are prepared by pharmacies rather than manufactured and reviewed as finished drugs. The quantity in this recall is small compared with some earlier compounded GLP-1 recalls, but the firm classified the action as nationwide.

Why it was recalled

The stated reason for the recall is a lack of assurance of sterility. Tirzepatide and NAD+ are given by injection, and regulators treat a sterility assurance failure in an injectable product as a serious quality defect because a contaminated injectable can, in general, introduce infection or other harm directly into the body. That describes why sterility is treated as critical for injectable drugs generally; it is not a statement that any specific patient who used the recalled product has been harmed, and the recall notice does not report confirmed contamination of any individual vial.

What a Class II recall means

The FDA sorts recalls into three classes by the level of hazard. A Class II recall, the middle tier, is defined by the agency as a situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or in which the probability of serious adverse health consequences is remote. The FDA classified the Apothecary Pharma recall as Class II, with a classification date of October 8, 2026 and a report date of October 14, 2026 in the agency's weekly Enforcement Report. A recall classification reflects the FDA's assessment of potential risk from the defect; it is not a finding that harm has occurred, and it does not by itself establish that any individual patient's medication caused an injury.

The December 2025 warning letter and prior inspection

The recall follows earlier FDA scrutiny of the same facility. In a warning letter dated December 1, 2025, the FDA told Apothecary Pharma that drug products it produced failed to meet the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act and that investigators had noted, in the agency's words, serious deficiencies in the firm's practices for producing drug products intended or expected to be sterile, which put patients at risk. Investigators inspected the Cary site from May 12 to May 15, 2025 and issued a Form FDA 483, the list of observations investigators leave with a firm. The warning letter stated that the firm ceased sterile drug production as of May 12, 2025 and notified the FDA of an intent to resume sterile production on August 1, 2025.

The same letter cited labeling deficiencies for products that included Tirzepatide Injection 10 mg/mL and semaglutide injection 2.5 mg/mL, among them missing active and inactive ingredient information and missing directions for use. A warning letter and a Form FDA 483 are steps in the FDA's compliance process: a 483 records observations from an inspection, and a warning letter sets out violations the agency believes it has found and asks for correction. Neither is a final court judgment, and a firm can respond and make changes. The October 2026 recall is a separate, firm-initiated action, but it sits against that documented backdrop of sterility concerns at the facility.

Why this matters for telehealth weight-loss patients

503B outsourcing facilities supply compounded medications in bulk to clinics and providers, which then dispense or administer them to patients. Compounded tirzepatide surged in use during recent shortages of branded GLP-1 drugs and is often prescribed through online weight-loss programs and telehealth clinics, then shipped to patients or given in office. In that model, a patient frequently does not see the name of the compounding pharmacy on the label and may be several steps removed from the facility that prepared the dose. A nationwide recall for a mailed or clinic-administered injectable therefore depends on prescribers and providers passing the notice down to the people who received the product.

What patients and prescribers can do

This is general information, not medical advice. If you use compounded tirzepatide or a compounded NAD+ injection, the following steps are consistent with how the FDA advises patients to handle drug recalls and reports:

• Ask your prescriber or the clinic or telehealth program that supplied your medication whether Apothecary Pharma, LLC was the compounding pharmacy, and whether your specific product and lot are part of the recall.
• Do not use any injectable that contains visible particles, cloudiness or discoloration, and follow your provider's instructions about a product identified as recalled.
• Keep the vial, label and any packaging or paperwork, which can help your provider and the pharmacy match your product to affected lots.
• If you have used a recalled product and feel unwell, contact your prescribing clinician or seek medical care.
• Report any adverse event or quality problem to the FDA's MedWatch program online or by calling 1-800-332-1088.