Posaconazole Recall: Noxafil Powdermix 300 mg (8 packets)
Announced 2025-12-31 · FDA
FDA is recalling Noxafil Powdermix (posaconazole) for delayed-release oral suspension, 300 mg, 8 packets per carton (Rx Only). The recall is due to potential presence of metal particulates in the product. Approximately 845 kits distributed nationwide in the USA are affected across lots Z012339, Z010344, Z009908, Z009909 with expiration date 12-31-2026.
| Brand | Merck Sharp & Dohme LLC |
|---|---|
| Product | 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. |
| Reason | Presence of particulate matter: potential presence of metal particulates in the product. |
| Severity | moderate |
| Units affected | 3 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026 |
WHAT YOU SHOULD DO
- Do not use any product from affected lots.
- Check your packaging for lot numbers Z012339, Z010344, Z009908, Z009909 and expiration date 12-31-2026.
- Contact your healthcare provider or pharmacist for guidance and possible replacement.
- Return or dispose of the recalled product as directed by your pharmacist or the FDA.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.