Diazepam Oral Solution — Class II drug recall D-0558-2022
Terminated recall by Lannett Company, Inc., reported 2022-02-23, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification results for related substances.
| Recall number | D-0558-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2022-02-09 |
| Classified | 2022-02-14 |
| Reported by FDA | 2022-02-23 |
| Terminated | 2023-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 23,598 bottles |
| Reason classes | specification failure |
| NDC | 00527-1768-36 |
| Lot numbers | 2664A, 2664B, 2874A, 2874B |
| Expiration dates | 2022-07, 2023-01 |
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 for recall
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0558-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.