Noxafil Powdermix recall (Merck Sharp & Dohme LLC)
DrugClass IIOngoing
Summary: Merck Sharp & Dohme LLC is recalling 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 00. Reason: Presence of particulate matter: potential presence of metal particulates in the product.
What is being recalled
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.
Why
Presence of particulate matter: potential presence of metal particulates in the product.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0242-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 12, 2025 |
| Reported | December 31, 2025 |
| Company | Merck Sharp & Dohme LLC |
| Company location | Wilson, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 845 kits |
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