Recalls / Class II
Class IID-0241-2026
Product
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
- Brand name
- Emend
- Generic name
- Aprepitant
- Active ingredient
- Aprepitant
- Route
- Oral
- NDCs
- 0006-0461, 0006-0462, 0006-3862, 0006-0464, 0006-3066
- FDA application
- NDA021549
- Affected lot / code info
- Lot #: Z014503, Exp 11/15/2027
Why it was recalled
Presence of particulate matter: potential presence of metal particulates in the product.
Recalling firm
- Firm
- Merck Sharp & Dohme LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4633 Merck Rd W, N/A, Wilson, North Carolina 27893-9613
Distribution
- Quantity
- 3 - single dose kits
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-12
- FDA classified
- 2025-12-23
- Posted by FDA
- 2025-12-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0241-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.