Merck Sharp & Dohme LLC

• TemozolomideTemodar · 7 products
• LetermovirPrevymis · 6 products
• RaltegravirIsentress · 5 products
• Sitagliptin and metformin hydrochlorideZituvimet XR, Zituvimet, Janumet · 5 products
• PosaconazoleNoxafil · 4 products
• SuvorexantBelsomra · 4 products
• Ertugliflozin and metformin hydrochlorideSegluromet · 4 products
• AprepitantEmend, Cinvanti, Aponvie · 4 products
• VericiguatVerquvo · 3 products
• SitagliptinJanuvia, Zituvio, Brynovin · 3 products
• Caspofungin acetateCancidas · 2 products
• ErtugliflozinSteglatro · 2 products
• FidaxomicinDificid · 2 products
• Ertugliflozin and sitagliptinSteglujan · 2 products
• SugammadexBridion · 2 products
• Pembrolizumab and berahyaluronidase alfa-pmphKeytruda Qlex · 2 products
• Tedizolid phosphateSivextro · 2 products
• Elbasvir and grazoprevirZepatier · 1 product
• BelzutifanWelireg · 1 product
• IvermectinStromectol, Soolantra · 1 product
• DoravirinePifeltro · 1 product
• Doravirine, lamivudine, and tenofovir disoproxil fumarateDelstrigo · 1 product
• Ceftolozane and tazobactamZerbaxa · 1 product
• EnsifentrineOhtuvayre · 1 product
• Imipenem and cilastatin sodiumPrimaxin IV · 1 product
• Imipenem anhydrous, cilastatin, and relebactam anhydrousRecarbrio · 1 product
• Lipfendra1 product
• FosaprepitantFocinvez, Emend, Navitrux · 1 product
• Ertapenem sodiumInvanz · 1 product
• Doravirine, islatravirIdvynso · 1 product
• PembrolizumabKeytruda · 1 product
• ClesrovimabEnflonsia · 1 product
• Bacillus calmette-guerinTice Bcg · 1 product
• VorinostatZolinza · 1 product
• BezlotoxumabZinplava · 1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2025

1. December 12, 2025 · Class II · Ongoing · D-0241-2026 · Aprepitant

   Presence of particulate matter: potential presence of metal particulates in the 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

2. December 12, 2025 · Class II · Ongoing · D-0242-2026 · Posaconazole

   Presence of particulate matter: potential presence of metal particulates in the product.

   Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, T

3. July 21, 2025 · Class II · Ongoing · D-0584-2025 · Suvorexant

   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.

   Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Lab

2022

1. March 31, 2022 · Class II · Terminated · D-0746-2022 · Sitagliptin and metformin hydrochloride

   Presence of foreign substance: Presence of stainless steel particulates in tablets.

   Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., In

2021

1. March 15, 2021 · Class II · Terminated · D-0523-2021 · Suvorexant

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a

2. March 15, 2021 · Class II · Terminated · D-0524-2021 · Ertugliflozin

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

2020

1. December 21, 2020 · Class II · Terminated · D-0176-2021 · Ceftolozane and tazobactam

   Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the regist

   Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01

2012

1. December 12, 2012 · Class II · Terminated · D-139-2013 · Temozolomide

   Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.

   Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033

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1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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