Merck Sharp & Dohme LLC

FDA Regulatory Profile

Summary

Total Recalls
5 (1 Class I)
510(k) Clearances
0
Inspections
59
Compliance Actions
0

Known Names

merck sharp and dohme, merck, sharp and dohme

Recent Recalls

NumberClassProductDate
D-0241-2026Class IIMerck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: MeDecember 12, 2025
D-0242-2026Class IINoxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, December 12, 2025
D-0746-2022Class IIJanumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottleMarch 31, 2022
D-0093-2022Class ICubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck ShOctober 19, 2021
D-0176-2021Class IIZerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. December 21, 2020