（NewsNation）——美国食品药品监督管理局（FDA）已对Apothecary Pharma LLC生产的23支GLP-1复方药瓶发布召回令，原因是无法确保这些药瓶的无菌性。根据FDA网站信息，FDA将此次召回定性为II类，意味着接触这些产品可能导致可逆或暂时性的健康后果，且因使用而导致严重后果的风险极小。
(NewsNation) — The FDA has issued a recall for 23 GLP-1 compounded vials from Apothecary Pharma LLC due to lack of assurance the vials are sterile. The FDA has designated the recall as Class II, meaning exposure to the products could cause reversible or temporary health consequences and poses little risk of serious consequences from use, according to the FDA website.
此次召回涉及22支替尔泊肽注射液，浓度18mg/mL，规格4毫升无菌多剂量药瓶，仅限凭处方使用，生产商为Apothecary Pharma, LLC，地址：北卡罗来纳州卡里市Evans Road 1913号，邮编27513，国家药品代码（NDC）85091-001-18。替尔泊肽用于Zepbound和Mounjaro。消费者应留意以下特定代码：此次召回还涉及1支NAD+注射液，浓度200mg/mL，规格6毫升无菌多剂量药瓶，仅限凭处方使用，生产商为Apothecary Pharma, LLC，地址：北卡罗来纳州卡里市Evans Road 1913号，邮编27513，国家药品代码（NDC）85091-011-06。代码信息为：批号：AP-202647，使用期限（BUD）2026年10月13日。
Apothecary Pharma于2025年12月收到FDA的一封信，信中指出：“FDA调查人员注意到，预期或应当为无菌的药品是在不卫生的条件下制备、包装或储存的，因此可能已被污物污染或变得对健康有害，导致贵公司的药品根据《联邦食品、药品和化妆品法》（FDCA）第501(a)(2)(A)条的规定被认定为掺假药。”
The recall applies to 22 vials of 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. Tirzepatide is used in Zepbound and Mounjaro. Customers should look out for these specific codes: The recall also applies to one vial of 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. The code information is: Lot #: AP-202647, BUD 13-Oct-2026 Apothecary Pharma in December 2025 received a letter from the FDA stating, "FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA."
Apothecary Pharma LLC是一家位于北卡罗来纳州的复方药房。复方GLP-1药物未经FDA批准，也非品牌药。这些药房为患者定制药物版本，而非像商业药房那样大规模生产，它们可以调整药物并创造新版本以满足患者的特定需求。根据《哈佛健康出版》（Harvard Health Publishing）的一篇文章，尽管这些药房使用FDA批准的成分，但其产品本身未经过有效性、安全性或纯度的检查。FDA偶尔会在药品短缺期间授权这些药房批量生产药物。
Apothecary Pharma LLC is a compounding pharmacy in North Carolina. Compounded GLP-1s are not FDA-approved or name-brand. These pharmacies create customized versions of drugs for patients rather than mass-producing them like a commercial pharmacy, and they can adjust medications and create new versions to meet the patient's specific needs Although these pharmacies use FDA-approved ingredients, the products themselves are not checked for effectiveness, safety or purity, according to an article in Harvard Health Publishing. The FDA occasionally grants these pharmacies permission to produce drugs in bulk during shortages.
2022年，配制药房获准自行生产GLP-1类药物，以填补当时的短缺。然而，据《药房时报》报道，替尔泊肽和司美格鲁肽已于2024年底和2025年初从药品短缺名单中移除。尽管不再存在短缺，配制药房仍继续生产GLP-1类药物。美国食品药品监督管理局（FDA）尚未发布官方指导说明，如果发现购买了被召回的药瓶该如何处理；目前尚无疾病病例与该召回有关联。消费者应停止使用，并联系其医疗服务提供者寻求指导。
In 2022, compounders were given permission to produce their own GLP-1 drugs to fill a shortage at the time. However, tirzepatide and semaglutide were removed from the drug shortage list in late 2024 and early 2025, according to Pharmacy Times reporting. Compound pharmacies continue to produce GLP-1s despite the lack of a shortage. The FDA has not released official instructions on what to do if you discover you purchased a recalled vial; no illnesses have been linked to the recall at this time. Consumers should stop using it and contact their healthcare provider for guidance.