Why it was recalled
Presence of particulate matter: potential presence of metal particulates in the product.
Product description
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 numbers, UPCs & expiration codes
Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0242-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 12, 2025
- FDA report date
- Dec 31, 2025
- Quantity
- 845 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Merck Sharp & Dohme LLC
Original FDA data
Every field from FDA enforcement report D-0242-2026, exactly as published.
Show all FDA fields
- City
- Wilson
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 98113
- Address
- 4633 Merck Rd W
- Code information
- Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
- Postal code
- 27893-9613
- Report date
- Dec 31, 2025
- Product type
- Drugs
- Recall number
- D-0242-2026
- Classification
- Class II
- Recalling firm
- Merck Sharp & Dohme LLC
- Product quantity
- 845 kits
- Reason for recall
- Presence of particulate matter: potential presence of metal particulates in the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 12, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2025