Unrated Drug recall · FDA · Published July 11, 2022

Hikma Ativan Injection Recall: Impurities May Cause Harm

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.

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

🇺🇸 FDA recall #D-1308-2022Drug Hikma Pharmaceuticals ›

Recall notice

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

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 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).

The FDA announced on July 11, 2022, that Hikma Pharmaceuticals USA Inc. voluntarily recalled Ativan Injection due to failed impurity specifications. The recall affects 301,400 vials distributed nationwide.

How to tell if you have it

Brand: Hikma Pharmaceuticals
Product: Ativan Injection (lorazepam injection, USP)
Strength/Size: 2mg/mL, 1 mL vial
Packaging: 25 vials per carton
Carton NDC: 0641-6001-25
Vial NDC: 0641-6001-01
Lot Code: 060064Z
Expiration Date: 06/2023
Manufacturer: West-Ward

The hazard

The recall was initiated because out-of-specification results were observed for total related compounds during testing of retain samples, according to the FDA.

Context

GovInfoNow's records show Hikma Pharmaceuticals USA INC has 14 other recalls on record since December 17, 2019. Other recent recalls of similar products include Hikma Ramipril Capsules (August 24, 2026), Hikma Alendronate Sodium Oral Solution (April 7, 2026), and Hikma Lorazepam Injection (July 22, 2025).

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

FDA recall event · 4 products

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

Based on the official FDA remedy

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.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “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 terminated this recall 14 months after the firm started it.

Jul 11, 2022Firm started the recall
Aug 5, 2022FDA classified it Class II
Aug 17, 2022Published in FDA’s Enforcement Report
Sep 14, 2023FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the expiration date for the recalled product?

The recalled product expires on 06/2023 (June 2023).

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Link to this recall

<a href="https://govinfonow.com/recall/34430-hikma-ativan-injection-recall-impurities-may-cause-harm">Hikma Ativan Injection Recall: Impurities May Cause 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-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.