Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufacture
Summary
The FDA issued a Class II for Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 by Merck Sharp & Dohme LLC. Reason: Presence of particulate matter: potential presence of metal particulates in the product..
Details
Source
Drug Recall
External ID
D-0242-2026
Action Date
2025-12-31
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Quantity Affected: 845 kits
Reason for Recall
Presence of particulate matter: potential presence of metal particulates in the product.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-12
Company
Wilson, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 19 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Merck Sharp & Dohme LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Merck Sharp & Dohme LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Merck Sharp & Dohme LLC have FDA actions?
Merck Sharp & Dohme LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0242-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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