thejoe Lorazepam

Lorazepam recalls: 12 FDA reports

Recalls involving Lorazepam. What was wrong with each batch, and how the FDA graded the risk.

12Reports

1Class I

4Ongoing

2025-08-06Most recent

1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	10
Class III	1
Class I	1

By year reported

Year	Reports
2013	1
2017	2
2022	4
2023	1
2025	4

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, N

D-0551-2025 · Class II · reported 2025-08-06 · Ongoing

Why it was recalled: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Product: Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Where it went: Distributed Nationwide in the USA
How much: 382,775 1mL vials

Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug pr

D-0226-2025 · Class II · reported 2025-02-26 · Ongoing

Why it was recalled: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Product: Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
Where it went: Nationwide U.S. and Puerto rico
How much: 82,281 cartons

Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug prod

D-0227-2025 · Class II · reported 2025-02-26 · Ongoing

Why it was recalled: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Product: Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
Where it went: Nationwide U.S. and Puerto rico
How much: 94,349 cartons

Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug prod

D-0228-2025 · Class II · reported 2025-02-26 · Ongoing

Why it was recalled: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Product: Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
Where it went: Nationwide U.S. and Puerto rico
How much: 27,525 cartons

Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 06

D-0574-2023 · Class II · reported 2023-05-24 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Product: 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.
Where it went: Nationwide in the USA and Puerto Rico
How much: 1,352,475 vials

Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by

D-1308-2022 · Class II · reported 2022-08-17 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Product: Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
Where it went: Nationwide in the USA
How much: 301,400 vials

Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Ber

D-1309-2022 · Class II · reported 2022-08-17 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Product: Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Where it went: Nationwide in the USA
How much: 713,550 vials

Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Ber

D-1310-2022 · Class II · reported 2022-08-17 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Product: Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Where it went: Nationwide in the USA
How much: 82,700 vials

Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontow

D-1307-2022 · Class II · reported 2022-08-17 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Product: Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
Where it went: Nationwide in the USA
How much: 4,739,000 vials

Class I

Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branc

D-0120-2018 · Class I · reported 2017-12-27 · Terminated

Why it was recalled: Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Product: Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Where it went: Nationwide
How much: 136376 bottles

Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield,

D-0085-2018 · Class II · reported 2017-11-29 · Terminated

Why it was recalled: Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Product: Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Where it went: Nationwide in the USA
How much: 2952 500-count bottles

Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-600

D-580-2013 · Class III · reported 2013-06-12 · Terminated

Why it was recalled: Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Product: Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Where it went: Distribution was made to IN.
How much: 1,644 bottles

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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