Lorazepam Injection — Class II drug recall D-0574-2023
Terminated recall by Hikma Pharmaceuticals USA Inc., reported 2023-05-24, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observe
| Recall number | D-0574-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2023-05-11 |
| Classified | 2023-05-15 |
| Reported by FDA | 2023-05-24 |
| Terminated | 2023-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,352,475 vials |
| Reason classes | specification failure |
| NDC | 00641-6044, 00641-6044-01, 00641-6044-25, 00641-6045, 00641-6045-01, 00641-6045-25, 00641-6046, 00641-6046-01, 00641-6046-10, 00641-6047, 00641-6047-01, 00641-6047-10 |
| Lot numbers | 070086, 070128 |
| Expiration dates | 2023-07 |
Product
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
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-0574-2023. 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.