Emend Capsule
FDA Recall NDC 0006-0461
Latest: Class II · Status: Ongoing · Initiated Dec 12, 2025 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Emend (NDC 0006-0461). A significant event, classified as Class II, was initiated on Dec 12, 2025 by Merck Sharp & Dohme Llc. The reported reason for this action was: "Presence of particulate matter: potential presence of metal particulates in the product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of particulate matter: potential presence of metal particulates in the product.
Dec 12, 2025
Dec 31, 2025
3 - single dose kits
Recall Profile & Regulatory Data
Event ID
98113
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Merck Sharp & Dohme LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03
Batch or Lot Expiration Information
Lot# : Z014503, Exp 11/15/2027
Affected Packages Involved in this Recall
0006-0461-02Emend
0006-0461-01Emend
0006-0461-06Emend
0006-0461-12Emend
0006-0462-01Emend
0006-0462-06Emend
0006-3862-03Emend
0006-3862-13Emend
0006-0464-01Emend
0006-0464-10Emend
0006-0464-05Emend
0006-3066-01Emend
0006-3066-03Emend
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
