The FDA has classified a voluntary nationwide recall of 22 vials of compounded tirzepatide — the active ingredient in Zepbound and Mounjaro — and one vial of a compounded NAD+ injection as Class II, citing a “lack of assurance of sterility,” according to the agency’s enforcement records. The recalling firm, Apothecary Pharma LLC of Cary, North Carolina, had already received an FDA warning letter in December 2025 over what the agency called serious deficiencies in its sterile drug-production practices.
What we know / What we don’t know
What we know
- FDA enforcement records D-0036-2027 and D-0037-2027, read directly in the FDA’s recall database, confirm Apothecary Pharma LLC of Cary, NC, voluntarily initiated the recall on September 24, 2026, and the FDA classified both as Class II on October 8, 2026.
- The tirzepatide recall covers 22 vials (18 mg/mL, 4 mL sterile multi-dose vials, NDC 85091-001-18), lots AP-202622 through AP-202644 (sequence skips AP-202626), with beyond-use dates from October 7 to November 26, 2026. The NAD+ recall covers one vial (200 mg/mL, 6 mL, NDC 85091-011-06), lot AP-202647, beyond-use date October 13, 2026. Distribution is nationwide.
- The stated reason in the FDA record is “Lack of Assurance of Sterility.” Class II means the FDA determined that use of the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
- In December 2025, the FDA sent Apothecary Pharma a warning letter citing “serious deficiencies” in its sterile drug-production practices that “put patients at risk,” per USA Today, Fox Business and Becker’s Hospital Review.
- National coverage is in agreement — USA Today, Fox Business, the New York Post, the Los Angeles Times and Gannett outlets report the same products, lot numbers, dates and background facts — and a corrections/withdrawals search surfaced no retractions. The recall remains ongoing, per Fox Business.
What we don’t know
- Which telehealth providers or retailers sold the affected vials. Fox Business and the New York Post report Apothecary Pharma supplied several telehealth providers, but the FDA record does not name them. Patients must check the vial’s own label.
- Whether any illnesses or injuries are linked to the vials — the FDA record identifies none.
- Whether the December 2025 warning-letter findings are connected to this recall — the FDA has not established a connection, per Fox Business.
- One reporting discrepancy: USA Today and lohud date the Class II classification to October 10; Fox Business and the FDA record say October 8. We use the FDA record’s date.
Key facts
Products: Tirzepatide Injection 18 mg/mL, 4 mL sterile multi-dose vial (NDC 85091-001-18); Apothecary NAD+ Injection 200 mg/mL, 6 mL sterile multi-dose vial (NDC 85091-011-06)
Recalling firm: Apothecary Pharma LLC, 1913 Evans Road, Cary, NC 27513
Recall numbers: D-0036-2027 (tirzepatide); D-0037-2027 (NAD+ injection)
Volume: 22 vials (tirzepatide); 1 vial (NAD+)
Classification: Class II, assigned by the FDA on October 8, 2026
Reason: Lack of Assurance of Sterility
Recall initiated: September 24, 2026 (voluntary, firm-initiated)
Distribution: Nationwide within the United States
Beyond-use dates: October 7 – November 26, 2026 (tirzepatide); October 13, 2026 (NAD+)
Status: Ongoing
Background
Tirzepatide is the active ingredient in the brand-name drugs Zepbound and Mounjaro, made by Eli Lilly — two of the blockbuster GLP-1 medicines reshaping American healthcare. The vials in this recall are not those brand-name products. They are compounded copies: custom formulations made by a specialized compounding pharmacy, which are not individually reviewed by the FDA for safety and effectiveness before they reach patients.
Compounded GLP-1s exploded in popularity while the FDA’s official drug-shortage list still included tirzepatide and semaglutide, a period when compounders filled the gap for millions of patients. The agency removed both drugs from the shortage list in late 2024 and early 2025, after which compounders were expected to stop mass-producing copies. Many kept going, and the FDA has spent the year since issuing warnings, proposing exclusions from the outsourcing-facility bulks list, and classifying recalls as it tightens scrutiny.
The scale of the market explains why even a 22-vial recall is national news: the Los Angeles Times reported that roughly one in eight US adults currently takes a GLP-1 medication. Because Apothecary Pharma supplied compounded tirzepatide to multiple telehealth providers, per Fox Business and the New York Post, patients who bought through third-party sellers may not realize the manufacturer’s name — which is why checking the vial label itself is the only reliable identification step.
Timeline
Apothecary Pharma received the FDA’s warning letter on its sterile-drug practices in December 2025. It voluntarily initiated the recall on September 24, 2026, notifying recipients by letter; the FDA classified it Class II on October 8, 2026. National coverage followed October 19–22, with USA Today publishing twice and the New York Post, Fox Business, the Los Angeles Times and Gannett outlets carrying the lot tables.
Verified details
The central facts come from the FDA’s own enforcement records — the primary source — which we read directly in the FDA recall database (D-0036-2027 and D-0037-2027). The tirzepatide description reads verbatim: “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 reason in both records reads verbatim: “Lack of Assurance of Sterility.” The distribution pattern reads verbatim: “Nationwide within the United States,” and the voluntary/mandated field: “Voluntary: Firm initiated.” Independent secondary sources agree on every material number, with zero conflicts beyond the classification-date variance noted above, and a corrections/withdrawals search found no revisions or retractions.
Recalled tirzepatide lots and beyond-use dates, copied character-for-character from the FDA record (sequence skips AP-202626; the NAD+ lot is AP-202647, beyond-use date 13-Oct-2026):
AP-202622 — 07-Oct-2026
AP-202623 — 08-Oct-2026
AP-202624 — 19-Oct-2026
AP-202625 — 10/20/2026
AP-202627 — 10/26/2026
AP-202628 — 10/27/2026
AP-202629 — 10/28/2026
AP-202630 — 10/31/2026
AP-202631 — 11/01/2026
AP-202632 — 11/03/2026
AP-202633 — 11/07/2026
AP-202634 — 11/08/2026
AP-202635 — 11/16/2026
AP-202636 — 11/17/2026
AP-202637 — 11/18/2026
AP-202638 — 11/19/2026
AP-202639 — 11/20/2026
AP-202640 — 11/21/2026
AP-202641 — 11/22/2026
AP-202642 — 11/24/2026
AP-202643 — 11/25/2026
AP-202644 — 11/26/2026
Independent secondary sources agree on every material number, with zero conflicts beyond the October 8 vs. October 10 classification-date variance noted above. The New York Post’s published lot table matches the FDA record exactly; Fox Business confirms the 22-vial and 1-vial volumes, the NDC numbers and the nationwide distribution; USA Today confirms the September 24 initiation and the Class II designation. A corrections/withdrawals search found no revisions or retractions of any of these details.
Why it matters
Three factors give this small recall outsized weight. First, the channel: compounded GLP-1s are sold through telehealth storefronts to patients who may never see a pharmacy label — the recall exposes how hard it is to trace a vial back to its maker. Second, the precedent: it is the second wave of compounded-tirzepatide enforcement this fall (Becker’s Hospital Review notes separate Carolina Infusion sterility recalls in the same FDA cycle), suggesting more actions may follow as the agency works through its post-shortage compounder crackdown. Third, the warning-letter history: the FDA told this same company nine months ago that its sterile-drug practices put patients at risk — this recall lands in that documented context.
Related coverage from USA Today on the copycat-GLP-1 crackdown, plus more US News at dailytrendusa.com, including the Brush Buddies toothpaste recall and the Kayem Foods hot dog and bacon recall.
What to do if you use compounded GLP-1 injections
Check the vial’s label — not the packaging it arrived in — for the manufacturer’s name and the lot number. If the vial reads Apothecary Pharma and the lot matches one of the table entries above (AP-202622 through AP-202644 for tirzepatide, AP-202647 for the NAD+ injection), do not use it; coverage of the recall advises contacting your prescriber or pharmacist for guidance on disposal and continuing treatment (Fox Business; NY Post). This is especially important if you bought through a telehealth provider, since you may not have realized which compounder made your vials.
This article is not medical advice. Anyone with questions about their medication should speak with their prescriber or pharmacist.
What happens next
The FDA lists the recall as ongoing, meaning the records can still be updated — with expanded lots, additional details or a close-out — so it is worth checking the FDA enforcement records (D-0036-2027 and D-0037-2027) rather than relying on a single news article. Daily Trend USA will update this story at the same URL if the recall expands or the FDA posts new information.
By the Daily Trend USA Newsroom. Verification: FDA enforcement records D-0036-2027 and D-0037-2027 (read directly via the FDA openFDA API); corroborated by USA Today, Fox Business, the New York Post, the Los Angeles Times and Gannett outlets (lohud, Providence Journal, Democrat and Chronicle); corrections/withdrawals search clean. Related coverage: the Virginia oyster salmonella recall. More US News at dailytrendusa.com.
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