Hikma Pharmaceuticals USA Inc. recalls Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward
Hikma Pharmaceuticals recalls Ativan injection due to failed impurities testing. This medication may contain harmful substances that could cause health issues. Affected lots: Lot #060064Z, Exp. 06/2023.
Recall notice
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Contact the company & request your remedy
What happened, in plain English
Hikma Pharmaceuticals is recalling Ativan injection (lorazepam) vials that may contain harmful impurities. This could pose health risks to patients using the medication as prescribed. Read more at govinfonow.com/recall/34430-hikma-ativan-injection-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/34430-hikma-ativan-injection-recall-impurities-may-cause-harm · Updated August 18, 2026 · FDA enforcement record: FDA #D-1308-2022
Cite this page
“Hikma Ativan Injection Recall: Impurities May Cause Harm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34430-hikma-ativan-injection-recall-impurities-may-cause-harm. Based on FDA recall #D-1308-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1308-2022%22&limit=1).
Why it’s dangerous
The medication failed impurities testing, meaning it may contain harmful substances. This could lead to health issues if the injection is used as intended.
Who’s affected
Patients prescribed Ativan injection by a doctor are affected. Those using the recalled lot numbers are at risk.
How to tell if you have this one
Check for the carton NDC# 0641-6001-25 and vial NDC# 0641-6001-01. The affected lot number is 060064Z, with an expiration date of 06/2023.
- Brand
Hikma Pharmaceuticals- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1307-2022 | 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; Lot # 060064, Exp. 06/2023, 070084, Exp. 07/2023, 070126, Exp. 07/2023, 080091, Exp. 08/2023, 080060, Exp. 08/2023 | 4,739,000 vials | 0641-6044-01, 0641-6044-25, 0641-6046-01, 0641-6046-10, 0641-6045-01, 0641-6045-25, 0641-6047-01, 0641-6047-10 |
| D-1308-2022 | 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; Lot # 060064Z, Exp. 06/2023 | 301,400 vials | 0641-6003-01, 0641-6003-25, 0641-6002-01, 0641-6002-10, 0641-6001-01, 0641-6001-25, 0641-6000-01, 0641-6000-10 |
| D-1309-2022 | 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; Lot # 070088, exp. date 07/2023 | 713,550 vials | 0641-6048-01, 0641-6048-25, 0641-6050-01, 0641-6050-10, 0641-6049-01, 0641-6049-25, 0641-6051-01, 0641-6051-10 |
| D-1310-2022 | 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; Lot # 070096, exp. date 07/2023 | 82,700 vials | 0641-6044-01, 0641-6044-25, 0641-6046-01, 0641-6046-10, 0641-6045-01, 0641-6045-25, 0641-6047-01, 0641-6047-10 |
What to do — step by step
Check Product Details
Look for the carton NDC# 0641-6001-25 and vial NDC# 0641-6001-01 on the packaging.
Questions people ask
Is this product safe to use?
The recall indicates the product may contain harmful impurities, so it is not safe to use as recalled.
What should I do if I have this product?
The official recall does not specify a remedy, so contact Hikma Pharmaceuticals for guidance.
What is the expiration date for the recalled product?
The recalled product expires on 06/2023 (June 2023).
Contact Hikma Pharmaceuticals
We’ve drafted a message you can send Hikma Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1308-2022 — Hikma Pharmaceuticals Hikma Pharmaceuticals Hello, I own a Hikma Pharmaceuticals that is covered by recall D-1308-2022 from Hikma Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1308-2022 (July 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1308-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.