Apothecary Pharma LLC Recall of Tirzepatide Injection 18mg/mL Vials

Apothecary Pharma LLC recalled 22 vials of Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, a prescription product, because of a lack of assurance of sterility, according to the FDA enforcement report for recall number D-0036-2027. The firm, at 1913 Evans Road, Cary, North Carolina, initiated the recall on September 24, 2026. The FDA classified it as a Class II recall on October 8, 2026, and the openFDA record lists its status as Ongoing. The recall covers 22 listed lots with beyond-use dates running from October to November 2026.

At a glance

• The recalling firm is Apothecary Pharma LLC, 1913 Evans Road, Cary, NC 27513, per the openFDA enforcement record for D-0036-2027.
• The recalled product is Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, NDC 85091-001-18.
• The stated reason for the recall is “Lack of Assurance of Sterility.”
• The FDA classified the recall as Class II, a designation the agency uses for products that may cause temporary or medically reversible health consequences.
• The distribution pattern is nationwide within the United States, and the firm initiated the action voluntarily.

What was recalled and why

The FDA enforcement record describes the product as 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. The recalled quantity is 22 vials. The stated reason is “Lack of Assurance of Sterility.”

The record lists 22 lots with distinct beyond-use dates (BUDs). Those lot numbers are AP-202622 through AP-202644 with some gaps, and the listed BUDs run from October 7, 2026, through November 26, 2026. Beyond-use dates are the dates after which a compounded preparation should no longer be used.

The firm’s initial notification method is listed as a letter. The record describes the recall as “Voluntary: Firm initiated,” which means the company began the removal rather than acting under a mandatory FDA order.

What a Class II classification means

The openFDA record gives the classification as Class II. In FDA recall practice, a Class II designation applies to a product that may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

The record does not describe any reported injury, infection, or adverse event tied to these vials. The classification describes potential risk, not a finding that harm occurred.

What “lack of assurance of sterility” means

The reason field states “Lack of Assurance of Sterility.” This is the FDA’s own wording for the recall reason as captured in the enforcement record. It concerns whether the product can be confirmed sterile, not a confirmed finding of contamination.

The record does not identify a specific organism, a failed test result, or a laboratory finding. It states the reason as a lack of assurance, and nothing more.

What is established vs. what is alleged

Established: the FDA enforcement record for recall number D-0036-2027 lists a voluntary, firm-initiated recall by Apothecary Pharma LLC of 22 vials of Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, NDC 85091-001-18, with the reason “Lack of Assurance of Sterility.”

Established: the recall initiation date is September 24, 2026, the center classification date is October 8, 2026, and the report date is October 14, 2026. The distribution pattern is nationwide within the United States.

Not established by this record: any claim that a patient was injured, that a vial was contaminated, or that the product failed a specific sterility test. The record does not state any of these. A recall reason of “lack of assurance” is the agency’s recorded rationale, not a judicial finding.

Where the claims stand procedurally

No federal court consolidation exists for this recall as of the source record’s last update on October 21, 2026. The source documents describe a regulatory action, not litigation. There is no multidistrict litigation (MDL, a procedure that centralizes related federal cases before one judge) and no reported trial date.

The relevant procedural posture is the FDA enforcement record itself: recall number D-0036-2027, classified Class II by the FDA on October 8, 2026, with a status of Ongoing as of the October 21, 2026 openFDA data update. A “Terminated” flag on the FDA’s drug recall index would indicate the agency determined all reasonable removal efforts were made; this record does not show termination.

Readers researching related product-liability patterns can review how GLP-1 litigation and compounded-product recalls are organized on this site. For general background on how product recalls fit into pharmaceutical claims, see the American Health Packaging metoclopramide recall.

Key dates

• September 24, 2026: Apothecary Pharma LLC initiated the voluntary recall of the tirzepatide vials.
• October 7, 2026: The earliest listed beyond-use date among the recalled lots (lot AP-202622).
• October 8, 2026: The FDA assigned the recall a Class II classification.
• October 14, 2026: The report date recorded in the openFDA enforcement entry.
• October 21, 2026: The openFDA data last_updated date, when the record still listed the recall as Ongoing.
• November 26, 2026: The latest listed beyond-use date among the recalled lots (lot AP-202644).

What this does not establish

The record does not show that any person became ill or was injured from these vials. It does not identify a contaminating organism or a failed laboratory test. It does not say the firm admitted fault, and it does not describe a recall of any other Apothecary Pharma product.

The record does not indicate whether every vial was recovered or destroyed. It does not give a monetary figure, a settlement, or a court ruling, because none appears in the source documents. It also does not establish that any lawsuit has been filed or consolidated.

Frequently asked questions

What did Apothecary Pharma LLC recall?

Apothecary Pharma LLC recalled 22 vials of Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, NDC 85091-001-18, according to the FDA enforcement record for recall number D-0036-2027. The stated reason is “Lack of Assurance of Sterility.” The firm is located at 1913 Evans Road, Cary, NC 27513.

When did the Apothecary Pharma tirzepatide recall begin?

The Apothecary Pharma tirzepatide recall was initiated on September 24, 2026. The FDA classified it as Class II on October 8, 2026, and recorded a report date of October 14, 2026. The openFDA record listed the recall as Ongoing as of its October 21, 2026 data update.

What does a Class II recall mean for this product?

A Class II designation is used by the FDA for a recalled product that may cause temporary or medically reversible health consequences, or where the probability of serious harm is remote. The record for recall number D-0036-2027 does not describe any reported injury or adverse event. The classification describes potential risk, not a finding that harm occurred.

Is there a lawsuit or MDL over these tirzepatide vials?

No federal court consolidation or MDL appears in the source documents for recall number D-0036-2027 as of October 21, 2026. The record describes a voluntary FDA-tracked recall, not litigation. The source documents do not report any filed case, trial date, or settlement connected to these vials.

Which lots and beyond-use dates are included in the recall?

The openFDA record lists 22 lots, from AP-202622 through AP-202644 with some gaps, each with its own beyond-use date. The listed beyond-use dates run from October 7, 2026, through November 26, 2026. Beyond-use dates mark when a compounded preparation should no longer be used.

Sources

1. openFDA (U.S. Food and Drug Administration): “Drug Enforcement Report, Recall Number D-0036-2027” (link, accessed 2026-10-30)
2. U.S. Food and Drug Administration: “Drug Recalls” (link, accessed 2026-10-30)
3. U.S. Food and Drug Administration: “Drug Safety Communications” (link, accessed 2026-10-30)
4. U.S. Food and Drug Administration: “Drugs@FDA Data Files” (link, accessed 2026-10-30)
5. U.S. Food and Drug Administration: “What’s New: Drugs RSS Feed” (link, accessed 2026-10-30)
6. U.S. Food and Drug Administration: “Drug Safety and Availability” (link, accessed 2026-10-30)