Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension

Merck Sharp & Dohme LLC has recalled Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 31, 2025 and was initiated on December 12, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, with approximately 845 kits affected. The company behind the recall is Merck Sharp & Dohme LLC, based in Wilson, NC. The FDA describes the product as: “Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon…”

Why was Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension recalled?

According to the FDA, the stated reason for the recall is: “Presence of particulate matter: potential presence of metal particulates in the product.” In plain terms, this recall relates to foreign material.

A foreign material recall means that pieces of something which should not be in food — such as metal, plastic, or glass — may be present. These can pose a choking hazard or cause injury. Recalls like these are issued to remove the affected product before anyone is hurt.

What should you do?

If you think you may have bought Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, compare it against the product description and identifying codes (Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Merck Sharp & Dohme LLC or your local health authority.

About this recall

This recall was distributed in NC. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.