Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class II · Moderate risk Ongoing Initiated Dec 12, 2025 (10 months ago)

Noxafil Powdermix (Posaconazole)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of particulate matter: potential presence of metal particulates in the product.

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

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.

Affected NDC 0085-2224-02

Compare with the code on your package — it is the most precise check available.

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Noxafil
posaconazole
NDC 00085-2224
300 mg/1 Powder, for Suspension
Oral
Merck Sharp & Dohme LLC Rx
Recalling firm
Merck Sharp & Dohme LLC
NDC code
0085-2224-02
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0242-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other recalls by Merck Sharp & Dohme LLC

All 2025 recalls
Class II · Moderate risk

Merck Emend

Presence of particulate matter: potential presence of metal particulates in the product.

Ongoing Particulate / foreign matter Merck Sharp & Dohme LLC NDC 0006-3066-03 D-0241-2026
Class II · Moderate risk

Zerbaxa (ceftolozane and tazobactam)

Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.

Terminated Sterility / contamination Merck Sharp & Dohme NDC 67919-030-01 D-0176-2021

Other particulate / foreign matter recalls from 2025

All particulate / foreign matter recalls