FDA Drug recall D-0253-2025
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health,…
- FDA Drug
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health,… by Safecor Health, citing defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0253-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-17 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Safecor Health |
| Distribution | US |
Product
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
Reason
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Identifiers
| code_info | Lot #s: a) 24210274, Exp 01/31/2025; 24401700, Exp 04/25/2025; b) 24251067, Exp 03/25/2025; 24421733, Exp 06/03/2025;…Lot #s: a) 24210274, Exp 01/31/2025; 24401700, Exp 04/25/2025; b) 24251067, Exp 03/25/2025; 24421733, Exp 06/03/2025; c) 24261384, Exp 03/24/2025; 24370127, Exp 04/28/2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0253-2025%22
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