Merck Sharp & Dohme

FDA Regulatory Profile

Merck Sharp & Dohme appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 59 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0241-2026, Class II) was initiated on Dec 12, 2025.

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: MeDec 12, 2025
D-0242-2026Class IINoxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Dec 12, 2025
D-0746-2022Class IIJanumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottleMar 31, 2022
D-0093-2022Class ICubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck ShOct 19, 2021
D-0176-2021Class IIZerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. Dec 21, 2020