FDA Drug recall D-0558-2022
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., P…
- FDA Drug
- Class II
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class II recall of Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., P… by Lannett, citing failed Impurities/Degradation Specifications: Out of specification results for related substances.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0558-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-09 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | US |
Product
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
Reason
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Identifiers
| code_info | Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023 |
|---|
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-0558-2022%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.