FDA recall D-0242-2026

Merck Sharp & Dohme LLC · Class II · drug

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2025-12-12
Report date
2025-12-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wilson, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0242-2026