The Recall Desk
HighFDA (Drugs)·D-0253-2025·Announced 2025-03-12

Lorazepam Oral Syringes Recalled Due to Defective Delivery System Causing Leakage

Safecor Health, LLC is recalling Lorazepam 0.5 mg oral syringes nationwide due to a defective delivery system that causes leakage after repackaging.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall of a prescription drug with a defective delivery system causing observed leakage. The defect presents a risk of improper medication dosing. No injury has been reported in the source text, meeting the rubric criterion for score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Safecor Health, LLC is recalling Lorazepam 0.5 mg per 0.25 mL oral concentrate syringes (unit-dose) distributed nationwide. The recall affects 3,465 oral syringes packaged and distributed by Safecor Health, LLC, Columbus, Ohio.

A defective delivery system was observed in the syringes that causes leakage after the oral solution was repackaged into unit-dose syringes. This leakage may affect the intended dose delivered to patients.

The affected lot numbers and expiration dates are: NDC 00054353244 (lot 24210274, expires 01/31/2025; lot 24401700, expires 04/25/2025), NDC 00121077001 (lot 24251067, expires 03/25/2025; lot 24421733, expires 06/03/2025), and NDC 65162068784 (lot 24261384, expires 03/24/2025; lot 24370127, expires 04/28/2025).

Patients or caregivers who have received this medication should contact their healthcare provider or pharmacist if they have concerns about their prescription.

The recalled product

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.
Manufacturer
Safecor Health, LLC
Category
Drug
Hazard
Affected units
3,465

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 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.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Safecor Health, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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