FDA Drug recall D-0523-2021
Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0523-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
Product
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 subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 0006-0005-10 |
|---|---|
| ndc | 0006-0005-30 |
| ndc | 0006-0005-13 |
| ndc | 0006-0033-10 |
| ndc | 0006-0033-30 |
| ndc | 0006-0033-13 |
| ndc | 0006-0325-10 |
| ndc | 0006-0325-30 |
| ndc | 0006-0325-13 |
| ndc | 0006-0335-10 |
| ndc | 0006-0335-30 |
| ndc | 0006-0335-13 |
| code_info | 1778598 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0523-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.