Unrated Drug recall · FDA · Published July 22, 2025

Hikma Lorazepam Injection Recall: Impurities Risk Serious Harm

Hikma Pharmaceuticals recalls Lorazepam injection vials due to impurities that may cause serious harm. Affected products include 25 x 1mL vials with lot # K24118, expiring 10/31/2026. No remedy specified.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0551-2025Drug Hikma Pharmaceuticals ›

Recall notice

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

Take action

Contact the company

Recalling firmHikma Pharmaceuticals USA Inc.2 Esterbrook Ln · Cherry Hill, NJ 08003-4002

✎ GovInfoNow plain-language explainer

Hikma Pharmaceuticals is recalling Lorazepam injection vials because they contain impurities that could cause serious harm. This recall affects prescription-only vials manufactured in Berkeley Heights, New Jersey, with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/31958-hikma-lorazepam-injection-recall-impurities-risk-serious-harm.

Source Summary by GovInfoNow · govinfonow.com/recall/31958-hikma-lorazepam-injection-recall-impurities-risk-serious-harm · Updated August 17, 2026 · FDA enforcement record: FDA #D-0551-2025

Cite this page

“Hikma Lorazepam Injection Recall: Impurities Risk Serious Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31958-hikma-lorazepam-injection-recall-impurities-risk-serious-harm. Based on FDA recall #D-0551-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0551-2025%22&limit=1).

Hikma Pharmaceuticals USA Inc. voluntarily recalled Lorazepam Injection, USP due to failed impurity specifications, the Food and Drug Administration said July 22. The Class II recall affects 382,775 vials distributed nationwide.

How to tell if you have it

Brand: Hikma Pharmaceuticals
Product: Lorazepam Injection, USP, 2 mg/mL
Packaging: 25 x 1mL vials/carton
NDC#: 0641-6044-25
Lot #: K24118
Expiration date: 10/31/2026
Manufacturer: Hikma Berkeley Heights, NJ 07922

The hazard

The recall is due to out-of-specification total related compounds in the injection. The FDA classified the recall as Class II.

Context

GovInfoNow's records show Hikma Pharmaceuticals USA INC has 14 other recalls on record since 2019-12-17. Other recent recalls of similar products include Macleods Olanzapine Tablets 5mg Recall (2026-08-27), Sagent Busulfan Injection Recall (2026-05-04) and OneSource Specialty Pharma Methohexital Sodium Recall (2026-06-07).

How to tell if you have this one

Check for vials labeled 'Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton' with lot number K24118 and expiration date 10/31/2026. These were manufactured by Hikma Berkeley Heights, NJ.

Brand
Hikma Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the lot number and expiration date on the vial packaging to confirm if it matches the recalled batch.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

Jul 22, 2025Firm started the recall
Jul 31, 2025FDA classified it Class II
Aug 6, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Hikma Pharmaceuticals recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31958-hikma-lorazepam-injection-recall-impurities-risk-serious-harm">Hikma Lorazepam Injection Recall: Impurities Risk Serious Harm (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0551-2025 (July 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0551-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.