Ativan Lorazepam Injection Recalled Nationwide for Out-of-Specification Impurities
Nationwide recall of Ativan (lorazepam) injection lot 060064Z due to out-of-specification impurities and degradation products. Patients should contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard (out-of-specification impurities and degradation products) is a quality issue addressed through precautionary recall, not a confirmed safety incident with actual harm reported.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Ativan (lorazepam) injection, 2mg/mL, supplied in 1 mL vials packaged 25 vials per carton, distributed nationwide. The affected lot is 060064Z, with an expiration date of June 2023. The recall involves 301,400 vials total.
The recall was initiated following testing failures. Laboratory testing of retained samples revealed out-of-specification results for total related compounds. Impurities and degradation products in the samples exceeded acceptable limits.
Ativan injection is a prescription benzodiazepine. Patients who received medication from the recalled lot should contact their healthcare provider.
Healthcare providers should review patient records to identify if doses from the affected lot were administered and take appropriate action, including patient notification.
The recalled product
- Product
- ATIVAN (LORAZEPAM)
- Brand
- ATIVAN
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injectable Benzodiazepine
- Affected units
- 301,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 060064Z
- Exp. 06/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Hikma Pharmaceuticals USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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