FDA Recall D-0242-2026

Merck Sharp & Dohme LLC · Wilson, NC

Class II Ongoing 153 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026

Quantity: 845 kits

Reason for recall

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

Recall record

Recall number: D-0242-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-12-12
Classified by FDA Center: 2025-12-23
FDA published: 2025-12-31
Recalling firm: Merck Sharp & Dohme LLC
Firm location: Wilson, NC

Drug identification

Brand name(s): NOXAFIL
Generic name(s): POSACONAZOLE
Manufacturer(s): Merck Sharp & Dohme LLC
NDC(s): 0085-1328, 0085-4324, 0085-4331, 0085-2224
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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