Noxafil Solution
FDA Recall NDC 0085-4331
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Noxafil (NDC 0085-4331). A significant event, classified as Class II, was initiated on Dec 12, 2025 by Merck Sharp & Dohme Llc. The reported reason for this action was: "Presence of particulate matter: potential presence of metal particulates in the product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of particulate matter: potential presence of metal particulates in the product.
Dec 12, 2025
Dec 31, 2025
845 kits
Recall Profile & Regulatory Data
Event ID
98113
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Merck Sharp & Dohme LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# : Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Affected Packages Involved in this Recall
0085-1328-01Product
0085-4324-02Product
0085-4331-01Product
0085-2224-01Product
0085-2224-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
