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Class II · ModerateActive recall

Noxafil

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byN.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA
Brand nameNOXAFIL
Generic namePOSACONAZOLE
Active ingredient(s)POSACONAZOLE
Distributed by / forMerck Sharp & Doohme LLC, Rahway, NJ 07056 USA
NDC0085-2224-02
Show the full FDA record
Full product labelNoxafil 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.
Recalling firmMerck Sharp & Dohme LLC
DistributionNationwide in the USA
Quantity845 kits
Recall initiated2025-12-12
Report date2025-12-31
Recall completed—
Recall numberD-0242-2026
ClassificationClass II
FDA statusOngoing
Origin on fileWilson NC United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.