Class II · ModerateRecall completed

Lorazepam

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?

Check your lot numberLots: 070086, 070128, Exp. 07/2023

Where it was soldNationwide in the USA and Puerto Rico

Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

What to do

Check the lot number and expiry on your medicine against the recall above.
Talk to your pharmacist or doctor before changing anything — don't stop on your own.
Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byWest-Ward, Eatontown, NJ 07724

Brand name	LORAZEPAM
Generic name	LORAZEPAM
Active ingredient(s)	LORAZEPAM
Distributed by / for	Hikma Pharmaceuticals USA Inc.
NDC	0641-6044-01

Show the full FDA record

Full product label	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), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Recalling firm	Hikma Pharmaceuticals USA Inc.
Distribution	Nationwide in the USA and Puerto Rico
Quantity	1,352,475 vials
Recall initiated	2023-05-11
Report date	2023-05-24
Recall completed	2023-12-12
Recall number	D-0574-2023
Classification	Class II
FDA status	Terminated
Origin on file	Cherry Hill NJ United States

Recent drug recalls Check another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.