Lorazepam Oral Syringes Recalled Due to Leakage Defect

A Class II recall has been initiated for Lorazepam 0.5 mg per 0.25 mL Oral Syringes, manufactured by PAI and repackaged by Safecor Health, LLC. The recall affects 3465 oral syringes across multiple lot numbers (24210274, 24401700, 24251067, 24421733, 24261384, and 24370127) with expiration dates ranging from January 31, 2025, to June 3, 2025. The recall was prompted by reports of leakage from the unit-dose syringes, which could lead to inaccurate dosing and reduced drug effectiveness. The recall was voluntarily initiated on February 17, 2025, and remains ongoing.

The recalling firm, Safecor Health, LLC, based in Columbus, Ohio, has notified consignees through letters. The US Federal Drug Administration (FDA) classified the recall as Class II on March 5, 2025, indicating that use of the defective product may cause temporary or medically reversible health issues, but serious adverse effects are unlikely. Although no official press release has been issued, pharmacists are advised to immediately remove affected lots from inventory and ensure that patients receive properly dosed alternatives.

Lorazepam is a benzodiazepine used for the management of anxiety disorders, insomnia, and as a premedication for anesthesia. Leakage from the syringes can lead to inaccurate dosing, potentially reducing therapeutic efficacy or causing withdrawal symptoms in long-term users.