FDA Drugs recall ·
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension… recall
- Recall number
- D-0242-2026
- Date
- (initiated December 12, 2025)
- Company / brand
- Merck Sharp & Dohme LLC
4633 Merck Rd W, Wilson, NC, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 845 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of particulate matter: potential presence of metal particulates in the product.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0242-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.