CLASS II ONGOING Drug recall · Reported 31 Dec 2025 · FDA Enforcement Report
Noxafil Powdermix (posaconazole) recalled by Merck Sharp & Dohme
Merck Sharp & Dohme is recalling Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets, distributed nationwide in the US. The recall was initiated on 12 Dec 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0242-2026
- FDA event ID
- 98113
- Recalling firm
- Merck Sharp & Dohme, Wilson, NC
- Brand
- Noxafil
- Manufacturer
- Merck Sharp & Dohme LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Dec 2025
- FDA classified
- 23 Dec 2025
- Reported
- 31 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 12 Dec 2025 | Recall initiated by company | |
| 23 Dec 2025 | Classified by FDA | +11 days |
| 31 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter: potential presence of metal particulates in the product.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of particulate matter: potential presence of metal particulates in the product.
Which lots are affected?
Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98113This product is part of a recall event; the main page for the event is Merck Emend (aprepitant) for oral suspension, 125 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Merck Emend (aprepitant) for oral suspension, 125 mg recalledEmend | Merck Sharp & Dohme | Particulate Matter | Nationwide |
More recalls from Merck Sharp & Dohme
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Merck Emend (aprepitant) for oral suspension, 125 mg recalledEmend | Merck Sharp & Dohme | Particulate Matter | Nationwide |
| Drug | CLASS II | Janumet (sitagliptin and metformin HCl) tablets recalledJanumet | Merck Sharp & Dohme | Particulate Matter | Nationwide |
| Drug | CLASS I | Cubicin (daptomycin for injection), 500 mg per vial recalled | Merck Sharp & Dohme | Particulate Matter | Nationwide |
| Drug | CLASS II | Zerbaxa (ceftolozane and tazobactam) per vial for injection recalledZerbaxa | Merck Sharp & Dohme | Sterility | Nationwide |
Other Posaconazole recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Posaconazole Delayed-Release Tablets, 100 mg recalled by Biocon PharmaPosaconazole | Biocon Pharma | Potency & Assay | Nationwide |