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Merck & Co Inc

FDA Regulatory Profile

Merck & Co Inc has 5 FDA recalls, 33 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0584-2025 · Class II · Jul 21, 2025
Latest inspection
Mar 13, 2026 · NAI

Newer recall under related name Merck Sharp And Dohme: Dec 12, 2025, D-0242-2026.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls5Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections33Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Merck Sharp And Dohme
Same company group		50590Dec 12, 2025 (D-0242-2026)
Organon
Same company group		34200May 28, 2024 (D-0552-2024)
Organon Teknika
Same company group		113000Jan 11, 2019 (Z-0962-2019)
Cubist Pharmaceuticals
Same company group		4000Aug 8, 2014 (D-0229-2015)
Msd International
Same company group		00150—
Merck And Cie
Same company group		0080—
Organon Heist
Same company group		0080—
Intervet International
Same company group		0051—
Intervet
Same company group		0050—
Intervet Production
Same company group		0050—
Organon Pharma (Uk)
Same company group		0050—
Intervet Gesmbh
Same company group		0040—

Recent Recalls

NumberClassProductDate
D-0584-2025Class IIBelsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card…Jul 21, 2025
D-1311-2014Class IIILiptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30)…Jan 13, 2014
D-1310-2014Class IIILiptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30)…Jan 13, 2014
D-1309-2014Class IIILiptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30)…Jan 13, 2014
D-1312-2014Class IIILiptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30)…Jan 13, 2014

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 13, 2026Rahway, NJDrugsNo Action Indicated (NAI)2211017
Dec 18, 2025Rahway, NJBiologicsNo Action Indicated (NAI)2211017
May 16, 2025Rahway, NJDrugsNo Action Indicated (NAI)2211017
Mar 27, 2025Rahway, NJDrugsNo Action Indicated (NAI)2211017
Sep 1, 2023North Wales, PADrugsNo Action Indicated (NAI)3002721810
Nov 18, 2021Rahway, NJDrugsNo Action Indicated (NAI)2211017
Oct 27, 2021Rahway, NJDrugsNo Action Indicated (NAI)2211017
Jan 20, 2021Rahway, NJDrugsVoluntary Action Indicated (VAI)2211017
Sep 6, 2019Rahway, NJDrugsNo Action Indicated (NAI)2211017
Apr 26, 2019South San Francisco, CABiologicsNo Action Indicated (NAI)3012116882
Nov 1, 2018North Wales, PADrugsNo Action Indicated (NAI)3002721810
Oct 30, 2017Rahway, NJDrugsVoluntary Action Indicated (VAI)2211017
Dec 6, 2016Rahway, NJDrugsNo Action Indicated (NAI)2211017
Sep 20, 2016North Wales, PADrugsVoluntary Action Indicated (VAI)3002721810
Aug 26, 2016Rahway, NJDrugsVoluntary Action Indicated (VAI)2211017
Apr 12, 2016North Wales, PADrugsVoluntary Action Indicated (VAI)3002721810
Nov 19, 2015Rahway, NJDrugsVoluntary Action Indicated (VAI)2211017
Feb 23, 2015Rahway, NJDrugsOfficial Action Indicated (OAI)2211017
May 19, 2014Rahway, NJDrugsVoluntary Action Indicated (VAI)2211017
Oct 16, 2013Rahway, NJDrugsVoluntary Action Indicated (VAI)2211017

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 2211017Rahway, NJ16Mar 13, 2026
FEI 3002721810North Wales, PA5Sep 1, 2023
FEI 3012116882South San Francisco, CA1Apr 26, 2019
FEI 3003108227Springfield, NJ2May 2, 2012
FEI 2211256Union, NJ3Apr 20, 2012
FEI 2210048Kenilworth, NJ3Mar 29, 2012
FEI 3002695895Springfield, NJ3Feb 29, 2012

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.