Hikma Lorazepam Injection Recall: Impurities May Cause Harm
Hikma Pharmaceuticals recalls Lorazepam injection vials due to impurities that could cause harm. Affected lots expire July 2023. Contact for details.
Lower-risk recall
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Contact the company
What happened, in plain English
Hikma Pharmaceuticals is recalling Lorazepam injection vials that may contain impurities. This could cause harm if used improperly. The recall affects specific lots manufactured between 2023. Read more at govinfonow.com/recall/33491-hikma-lorazepam-injection-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/33491-hikma-lorazepam-injection-recall-impurities-may-cause-harm · Updated August 17, 2026 · FDA enforcement record: FDA #D-0574-2023
Cite this page
“Hikma Lorazepam Injection Recall: Impurities May Cause Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33491-hikma-lorazepam-injection-recall-impurities-may-cause-harm. Based on FDA recall #D-0574-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0574-2023%22&limit=1).
Why it’s dangerous
The injection vials may have impurities that could cause harm when used. This issue was detected during quality testing but does not indicate immediate danger in normal use.
Who’s affected
Prescription patients who received the recalled Lorazepam injection vials. Healthcare providers using these vials for medical treatment are most at risk.
How to tell if you have this one
Check for vials labeled 'Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01)' in packages of 25 vials. The affected lots are 070086 and 070128, expiring July 2023.
- Brand
Hikma Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Label
Look for the NDC code 0641-6044-01 on the vial and the lot numbers 070086 or 070128.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates potential impurities that could cause harm, but the product is safe for use if it's not part of the affected lots.
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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-0574-2023 (May 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0574-2023 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.