Whitehouse Station, NJ, United States
MERCK SHARP & DOHME CORP recalls
4 recalls recorded since 2018, most recently on 12 December 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)1
Ongoing Class II Drugs
- Recall started
- 12 December 2025
- Reason
- Presence of particulate matter: potential presence of metal particulates in the product.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0241-2026, D-0242-2026
- 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, Irelan
- 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
Terminated Class II Drugs
- Recall started
- 31 March 2022
- Terminated
- 15 August 2023
- Reason
- Presence of foreign substance: Presence of stainless steel particulates in tablets.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0746-2022
- 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
Terminated Class I Drugs
- Recall started
- 19 October 2021
- Terminated
- 25 July 2023
- Reason
- Presence of Particulate Matter: Identified as Glass Particles
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0093-2022
- Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceutica
Terminated Class II Drugs
- Recall started
- 21 December 2020
- Terminated
- 4 December 2023
- Reason
- 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 registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0176-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.