Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carto...
FDA Recall #D-0242-2026 — Class II — December 12, 2025
Product Description
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.
Reason for Recall
Presence of particulate matter: potential presence of metal particulates in the product.
Recalling Firm
Merck Sharp & Dohme LLC — Wilson, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
845 kits
Distribution
Nationwide in the USA
Code Information
Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated