Class IIOngoing

Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension recall

FDA recall D-0242-2026 · initiated Dec 12, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Presence of particulate matter: potential presence of metal particulates in the product.

Details

Product: 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 & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.
Recalling company: Merck Sharp Dohme
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Dec 12, 2025
FDA report date: Dec 31, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0242-2026 ↗

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