LORAZEPAM

Generic: LORAZEPAM

Rising Pharma HoldingsManufacturer
ORALRoute
LORAZEPAMActive Substance
2025-07-24Original Approval

LORAZEPAM is FDA application ANDA218597, sponsored by GRAVITI PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2022-07-11
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heig

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total relate

Class II2017-09-28
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004

Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets o

Class II2022-07-11
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heig

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total relate

Class II2025-07-22
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, N

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

Class II2022-07-11
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 0772

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total relate

Class II2023-05-11
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compoun

Class I2017-08-03
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ

Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.

Top Reported Reactions

1
DRUG INEFFECTIVE
9,188 reports
2
FATIGUE
8,955 reports
3
NAUSEA
8,798 reports
4
OFF LABEL USE
7,790 reports
5
DIARRHOEA
7,183 reports
6
DYSPNOEA
6,261 reports
7
VOMITING
5,949 reports
8
HEADACHE
5,806 reports
9
ANXIETY
5,615 reports
10
DIZZINESS
5,595 reports