# FDA recall D-0253-2025

> **Safecor Health, LLC** · Class II · drug recall initiated 2025-02-17.

## 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 for recall

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0253-2025
- **Recalling firm:** Safecor Health, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-02-17
- **Report date:** 2025-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0253-2025

## Citation

> AI Analytics. FDA recall D-0253-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0253-2025. Source: US FDA. Licensed CC0.

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