HIGHFDA DRUG

Merck Recalls Noxafil Oral Suspension Due to Metal Contamination

Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
December 12, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
December 12, 2025
Hazard Level
HIGH
Brands
NOXAFIL, Merck Sharp & Dohme LLC
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
NOXAFIL, Merck Sharp & Dohme LLC
Product type
Oral Suspension
Model numbers
Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
UPC codes
0085-1328, 0085-4324, 0085-4331, 0085-2224, 0085-1328-01, 0085-4324-02, 0085-4331-01, 0085-2224-01 +1 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 12, 2025

  2. Reported by FDA DRUG

    December 31, 2025

  3. RecallRadar source check

    January 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Merck Sharp & Dohme LLC or your healthcare provider for guidance. Notification method: Letter

About This Product

Noxafil Powdermix is an antifungal medication used to prevent and treat fungal infections in immunocompromised patients. Consumers typically buy this medication on prescription to manage serious health conditions.

Why This Is Dangerous

The presence of metal particulates poses a serious health risk, as ingestion may lead to poisoning or other adverse health effects. This contamination compromises the product's safety and efficacy.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall affects consumers who rely on this medication for serious health conditions. The potential for serious health complications makes immediate action necessary.

Practical Guidance

How to identify if yours is affected

  1. Check the product packaging for lot numbers Z012339, Z010344, Z009908, or Z009909.
  2. Verify the expiration date, which should be December 31, 2026.
  3. If you have the product, stop using it immediately.

Where to find product info

Lot numbers and expiration dates can usually be found on the product packaging or labels.

What timeline to expect

Expect a refund processing time of 4-6 weeks after submission of your request.

If the manufacturer is unresponsive

  • Follow up with Merck via phone or email.
  • Document all communication attempts and keep records.

How to prevent similar issues

  • Always check for recalls before using medications.
  • Consult your healthcare provider before switching medications.
  • Be cautious of medications with reported quality issues.

Documentation advice

Keep a record of your purchase, including receipts and any correspondence with the manufacturer.

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Product Details

Noxafil Powdermix (posaconazole) is an oral suspension available in 300 mg packets. The recalled products were distributed nationwide in the USA. Lot numbers include Z012339, Z010344, Z009908, and Z009909, with an expiration date of December 31, 2026.

Key Facts

  • Potential metal contamination
  • Contact healthcare provider for guidance
  • Stop using immediately

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
POISONING

Product Classification

Product Details

Model Numbers
Lot#: Z012339
Z010344
Z009908
Z009909
Exp Date 12-31-2026
UPC Codes
0085-1328
0085-4324
0085-4331
+6 more
Affected States
ALL
Report Date
December 31, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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