Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC
Summary
The FDA issued a Class II for Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecar by Apothecary Pharma LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0036-2027
Action Date
2026-10-14
Status
Ongoing
Category
drug
Product Description
Tirzepatide 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/Code Info: 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 11/26/2026
Quantity Affected: 22 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-24
Company
Cary, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 67 drug-related FDA actions this month.
Apothecary Pharma LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apothecary Pharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apothecary Pharma LLC have FDA actions?
Apothecary Pharma LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0036-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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