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Stop using now Drug recall · FDA · Published September 24, 2026

Apothecary Pharma Recalls Tirzepatide Injections Due to Sterility Risk

Apothecary Pharma LLC is recalling specific lots of Tirzepatide Injection vials due to a lack of assurance of sterility. Check your lot numbers immediately.

🇺🇸 FDA recall #D-0036-2027DrugApothecary Pharma ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

Apothecary Pharma LLC has recalled Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial because the product lacks an assurance of sterility. The recall affects 22 vials distributed nationwide within the United States. This is a Class II recall issued on September 24, 2026. Read more at govinfonow.com/recall/1622874-apothecary-pharma-llc-recalls-tirzepatide-injection-18mg-ml-4-ml.

Source Summary by GovInfoNow · govinfonow.com/recall/1622874-apothecary-pharma-llc-recalls-tirzepatide-injection-18mg-ml-4-ml · Published October 21, 2026 · Updated October 21, 2026 · FDA enforcement record: FDA #D-0036-2027

Cite this page

“Apothecary Pharma Recalls Tirzepatide Injections Due to Sterility Risk.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1622874-apothecary-pharma-llc-recalls-tirzepatide-injection-18mg-ml-4-ml. Based on FDA recall #D-0036-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0036-2027%22&limit=1).

Why it’s dangerous

The primary hazard is a lack of assurance of sterility, meaning the vials may not be free from microorganisms. Using non-sterile injectable medication can lead to serious infections or adverse health reactions when introduced into the body.

Who’s affected

Patients who have been prescribed Tirzepatide Injection from Apothecary Pharma and possess vials with the specific lot numbers listed in the record. Individuals using these non-sterile vials are at risk of infection or other complications from contaminated medication.

How to tell if you have this one

Check your vial for the brand Apothecary Pharma and the NDC 85091-001-18. Verify if the lot number matches one of the following: AP-202622 through AP-202644. The expiration dates (BUD) range from October 7, 2026, to November 26, 2026.

  • Brand
    Apothecary Pharma
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Nationwide within the United States
Recall numberProduct, codes & lotsQuantity
D-0036-2027Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.; Lot #: 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 11/26/202622 vials
D-0037-2027Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.; Lot #: AP-202647, BUD 13-Oct-20261 vial
Based on the official FDA remedy

What to do — step by step

  1. Stop using the vial

    Do not use any Tirzepatide Injection vials that match the recalled lot numbers due to sterility concerns.

  2. Contact your healthcare provider

    Reach out to your doctor or pharmacist immediately to discuss alternative treatment options or replacement medication.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 20 days after the firm started it.

1. Firm started the recall: Sep 24, 202612. FDA classified it Class II: Oct 8, 202623. Published in FDA’s Enforcement Report: Oct 14, 202634. Added to GovInfoNow: Oct 21, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Which specific lot numbers are recalled?

The recalled lots are AP-202622, AP-202623, AP-202624, AP-202625, AP-202627, AP-202628, AP-202629, AP-202630, AP-202631, AP-202632, AP-202633, AP-202634, AP-202635, AP-202636, AP-202637, AP-202638, AP-202639, AP-202640, AP-202641, AP-202642, AP-202643, and AP-202644.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0036-2027 (September 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0036-2027 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA