← FDA ENFORCEMENT
D-0242-2026Class II

Merck Sharp & Dohme LLC

Recalling firm
Merck Sharp & Dohme LLC
Product type
Drug
Status
Ongoing
Report date
2025-12-31
Distribution
Nationwide in the USA
Firm state
NC
Product quantity
845 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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.

Code / lot info

Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.