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Drug FDA Class II Ongoing Foreign material

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 00

Merck Sharp & Dohme LLC Published Dec 31, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Merck Sharp & Dohme LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Metal Particulate · primary

Affected products (1)

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.

NOXAFIL · 845 kits

NDC: 0085-1328, 0085-4324, 0085-4331, 0085-2224, 0085-1328-01, 0085-4324-02, 0085-4331-01, 0085-2224-01, 0085-2224-02
Code info: Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 12, 2025
  2. Published
    Dec 31, 2025
Recall number
D-0242-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.