Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension recall
FDA recall D-0242-2026 · initiated Dec 12, 2025
Merck Sharp & Dohme LLC recalled Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension in Dec 2025 — an FDA Class II recall (D-0242-2026) because Presence of particulate matter: potential presence of metal particulates in the product.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of particulate matter: potential presence of metal particulates in the product.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 845 kits
Details
- 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.
- Recalling company
- Merck Sharp Dohme
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Dec 12, 2025
- FDA report date
- Dec 31, 2025
Frequently asked
- Was Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension recalled?
- Merck Sharp & Dohme LLC recalled Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension in Dec 2025 — an FDA Class II recall (D-0242-2026) because Presence of particulate matter: potential presence of metal particulates in the product. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0242-2026 was: Presence of particulate matter: potential presence of metal particulates in the product.
- Is a recalled Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0242-2026.