US Drug Recall Register
Class III · Low risk Terminated Initiated Mar 27, 2013 (13 years ago)

Lorazepam

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009

What was recalled

Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60

Recalling firm
Legacy Pharmaceutical Packaging LLC
NDC code
0904-6007-60
Origin
MO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-580-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Lorazepam recalls

See all
Class II · Moderate risk Ongoing

Lorazepam Injection

Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

Hikma Pharmaceuticals USA Inc. NDC 0641-6044-25 D-0551-2025
Class II · Moderate risk Ongoing

Lorazepam 0.5 mg per 0.25 mL Oral Syringe

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

Safecor Health, LLC D-0253-2025
Class II · Moderate risk Ongoing

Lorazepam Tablets

Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories D-0228-2025
Class II · Moderate risk Ongoing

Lorazepam Tablets

Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories D-0227-2025
Class II · Moderate risk Ongoing

Lorazepam Tablets

Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories D-0226-2025