Recalls / Class II
Class IID-0242-2026
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.
- Brand name
- Noxafil
- Generic name
- Posaconazole
- Active ingredient
- Posaconazole
- Route
- Oral
- NDCs
- 0085-1328, 0085-4324, 0085-4331, 0085-2224
- FDA application
- NDA022003
- Affected lot / code info
- Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Why it was recalled
Presence of particulate matter: potential presence of metal particulates in the product.
Recalling firm
- Firm
- Merck Sharp & Dohme LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4633 Merck Rd W, N/A, Wilson, North Carolina 27893-9613
Distribution
- Quantity
- 845 kits
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-12
- FDA classified
- 2025-12-23
- Posted by FDA
- 2025-12-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0242-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.