The compounded GLP-1 recall: which lots are affected and what to check

This page is general information, not medical advice. Recall lists change; check the FDA links in this guide for the current record.

What was recalled, in plain terms

Each of these recalls was started by the pharmacy itself ("voluntary: firm initiated") and then classified by FDA. All three are listed as Class II, all three are "Ongoing," and all three were distributed nationwide. FDA defines a Class II recall as a situation where use of the product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

"Lack of assurance of sterility" means the pharmacy can't show that the product was made in a way that keeps it sterile. It does not, by itself, mean contamination was found in your vial. But an injectable that may not be sterile is not something to keep using while you wait to find out.

Apothecary Pharma LLC (Cary, NC): tirzepatide vials

The pharmacy started it on September 24, 2026, by letter. FDA classified it on October 8, and it appeared in the Enforcement Report dated October 14, 2026.

• Product (recall D-0036-2027): "Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only," NDC 85091-001-18. Quantity: 22 vials.
• Lots and beyond-use dates (BUD), as listed: AP-202622, BUD 07-Oct-2026; AP-202623, BUD 08-Oct-2026; AP-202624, BUD 19-Oct-2026; AP-202625, BUD 10/20/2026; AP-202627, BUD 10/26/2026; AP-202628, BUD 10/27/2026; AP-202629, BUD 10/28/2026; AP-202630, BUD 10/31/2026; AP-202631, BUD 11/01/2026; AP-202632, BUD 11/03/2026; AP-202633, BUD 11/07/2026; AP-202634, BUD 11/08/2026; AP-202635, BUD 11/16/2026; AP-202636, BUD 11/17/2026; AP-202637, BUD 11/18/2026; AP-202638, BUD 11/19/2026; AP-202639, BUD 11/20/2026; AP-202640, BUD 11/21/2026; AP-202641, BUD 11/22/2026; AP-202642, BUD 11/24/2026; AP-202643, BUD 11/25/2026; AP-202644, BUD 11/26/2026.
• Same event, not a GLP-1: one vial of "Apothecary NAD+ Injection 200 mg/mL," lot AP-202647, BUD 13-Oct-2026 (recall D-0037-2027).

Carolina Infusion, LLC (Ridgeland, SC): tirzepatide and semaglutide syringes

The pharmacy started this recall on September 10, 2026, by email. FDA classified it on October 8, and it appeared in the October 14, 2026 Enforcement Report. The stated reason is "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product." These products were dispensed in patient-specific, single-use syringes.

The same Carolina Infusion event also lists other compounded injectables that are not GLP-1 medicines.

Houston Rx LLC (Houston, TX): tirzepatide/niacinamide vial

This recall was started on September 25, 2026, classified on October 13, and appeared in the October 21, 2026 Enforcement Report.

• Product (recall D-0040-2027): "Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only."
• Lot: TZN-080326-20/2-2, Beyond Use Date: 12/01/2026. Quantity: 64 vials.
• The same event lists one other compounded injectable that is not a GLP-1.

How to check your vial or syringe

1. Find the pharmacy name on the label or the shipping paperwork. These three FDA records name Apothecary Pharma LLC, Carolina Infusion, LLC and Houston Rx LLC. Other recalls can exist, so whatever the name, check FDA's current record (step 4).
2. Find the lot number and the BUD (beyond-use date). Compounded products use a BUD instead of a manufacturer's expiration date.
3. Match exactly. Compare every character of the lot number. Carolina Infusion lots look like "08262026@6," and Apothecary lots look like "AP-202630."
4. Check FDA's current record. Search the FDA Enforcement Report for the pharmacy name. Recalls can be expanded, updated or closed after this page was written.

What to do if your product matches

• Stop using it. Don't inject from a recalled vial or syringe, even if it looks normal.
• Call the pharmacy for return or replacement instructions, and tell your prescriber, who can decide how to keep your treatment going safely.
• Watch for signs of infection, such as fever or redness, swelling, warmth or pain at the injection site that gets worse. Get medical care promptly if they appear.
• Report problems to FDA MedWatch. Patients and clinicians can report side effects or product quality problems online, or by fax at 1-800-FDA-0178.

Compounded vs. FDA-approved GLP-1s

FDA says compounded drugs are not FDA-approved and are not reviewed by the agency for safety, effectiveness or quality. FDA also says they should be used only when a patient's medical need can't be met by an approved drug. FDA recommends getting a prescription from your doctor and filling it at a state-licensed pharmacy, and it points consumers to its BeSafeRx campaign for help buying prescription medicines online safely.

FDA has received adverse event reports for both compounded GLP-1s. As of May 31, 2026, the agency lists 990 reports involving compounded semaglutide and more than 730 involving compounded tirzepatide, and it notes that such reports are likely underreported. Those counts are not proof that the drug caused each event, but they are one reason FDA watches this category closely.

A few FDA handling points apply to any GLP-1 you inject:

• Don't use an injectable GLP-1 that arrives warm or without enough refrigeration.
• Throw away a multi-dose vial within 28 days after first use, even if medicine is left and even if the compounder's instructions say it lasts longer.
• Use a new sterile needle and syringe for every dose.

Use cases: what to do in common situations

• "My vial is from one of these pharmacies, but the lot isn't listed." Your lot isn't on the record as of this writing. Ask the pharmacy directly, and recheck FDA's record, because recalls can expand.
• "I already injected from a recalled lot." Don't panic. A Class II recall means serious harm is considered unlikely. Stop using it, tell your prescriber, and watch for signs of infection.
• "I use brand-name Zepbound, Mounjaro, Wegovy or Ozempic from a regular pharmacy." The products in these FDA records are compounded products from three pharmacies. Brand-name pens aren't listed in them.
• "I'm not sure what pharmacy filled my order." Check your shipping box, the label, or your telehealth account's order history, or ask your prescriber's office.
• "I want to switch away from compounded medication." That's a prescriber decision. Ask whether an FDA-approved option fits your situation and coverage. If nausea or eating changes come with a switch, see our guide to what to eat when a GLP-1 makes you nauseous. For what one FDA-approved pill involves day to day, see Foundayo: what to eat and what to expect.

Where Olive fits

Olive is a health companion app. It checks in with you every day, looks at what you eat, and helps you keep meals, protein and fluids steady when your routine gets thrown off. It can't tell you whether your vial is on a recall list, so use the steps above for that.

See how Olive works →

Medical disclaimer

This guide summarizes public FDA records and is not medical advice. Don't stop, start or change a prescription medicine without talking to your prescriber.