Merck Sharp Dohme’s FDA recall record

Every recall the FDA has published for a product we list under Merck Sharp Dohme. A count on its own says little — a company making more products will record more recalls — so the events themselves are shown, most recent first.

1 recall on record1 Class II — temporary or reversible harm

BELSOMRA20250721
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.

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Frequently asked questions

What does Merck Sharp Dohme make?

Merck Sharp Dohme makes prescription drugs. pharmaranks independently rates 19 of its products — see the full list below.

How is Merck Sharp Dohme rated?

pharmaranks gives Merck Sharp Dohme a composite rating of 3.6 out of 5, based on FDA regulatory (recall-safety) data across its products. See the source breakdown on this page.

Where is Merck Sharp Dohme headquartered?

Merck Sharp Dohme is headquartered in United States.

When was Merck Sharp Dohme founded?

Merck Sharp Dohme was founded in 1891.

Where this rating comes from

Our score is computed from public FDA data — not from opinion, sponsorship or user votes. How we rate.

FDA Drug Enforcement (recall) database — the recall history behind the safety score
DailyMed (NIH National Library of Medicine) — the FDA labels we quote for uses, dosing and warnings
Drugs@FDA — approvals, strengths and marketing status

Products (19)

crixivan

dutrebis

enflonsia

juvisync

keytruda

keytruda qlex

lotrisone

mintezol

noxafil

pepcid preservative free in plastic container

prevymis

rebetol

stromectol

temodar

victrelis

welireg

winrevair

zinplava

belsomra

Merck Sharp Dohme’s FDA recall record

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Where this rating comes from