Recall Issued for Lorazepam Tablets Due to Stability Concerns
The Harvard Drug Group, LLC has issued a voluntary recall of Lorazepam tablets USP, 0.5 mg. Distributed by Major Pharmaceuticals and packaged by Leading Pharma, LLC, the recall affects 82 281 cartons of unit-dose packaging containing 100 tablets per carton (10 x 10 blister packs). The affected product, identified under NDC 0904-6007-61, was found to be out-of-specification during routine stability testing, showing failed impurities/degradation specifications and subpotent drug levels. These issues raise concerns about the medication's efficacy and potential safety risks to patients.
The US Food and Drug Administration (FDA) has classified this as a Class II recall, indicating that exposure to the defective product may cause temporary or medically reversible adverse health consequences, but the likelihood of serious harm is low. The impacted lots have varying expiration dates ranging from March 2025 to August 2026 and were distributed nationwide, including Puerto Rico. The recall was initiated on January 21, 2025, and affected customers were notified by letter. It remains ongoing as of February 19, 2025.
Lorazepam is a prescription benzodiazepine commonly used to treat anxiety disorders, insomnia, and seizure disorders, as well as for sedation before medical procedures. As a central nervous system depressant, it helps calm excessive brain activity but requires careful dosing due to potential dependence and withdrawal risks. Pharmacists should check inventory for affected lot numbers, inform patients of potential medication potency issues, and consult health care providers for alternative options if necessary.
