Quality & complianceOfficial

FDA lists Class II recall of Apothecary Pharma NAD+ injection over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Apothecary Pharma's NAD+ Injection 200 mg/mL is subject to an ongoing nationwide US recall, classified Class II for lack of assurance of sterility.

The US Food and Drug Administration has published a Class II recall entry for Apothecary NAD+ Injection 200 mg/mL, made by Apothecary Pharma LLC. The entry, dated 14 October 2026, carries recall number D-0037-2027.

The stated reason for the recall is lack of assurance of sterility. The recall status is ongoing, and the product was distributed nationwide within the United States.

For context, FDA assigns Class II to recalls where use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote. The enforcement report text available to VigiEye did not include lot numbers, quantities, recall initiation dates or details of the sterility concern, so these are not reported here.

What it means for your team

  • Quality teams at compounders and outsourcing facilities should note that sterility-assurance failures on injectables continue to prompt recalls and review their own sterility controls accordingly.
  • Pharmacovigilance and clinical-supply contacts should check whether Apothecary NAD+ Injection 200 mg/mL is held in stock, and consult the full FDA enforcement report entry for lot and code details.
  • Because the recall is ongoing, the classification and scope could be updated, so teams should watch later enforcement reports.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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