Rahway, NJ, United States
Merck & Co. Inc recalls
1 recall recorded since 2018, most recently on 21 July 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 21 July 2025
- Reason
- 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.
- Distribution
- Nationwide in the USA and PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0584-2025
- 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
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.