Lorazepam injection vials failed the total related compounds impurity specification
Lorazepam Injection USP 2 mg/mL from Hikma is being recalled after an out-of-specification result for total related compounds. 382,775 1 mL vials are affected.
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 for an out-of-specification impurity result with no named compound or health consequence stated in the source.
Plain-English summary
Lorazepam Injection, USP, 2 mg/mL, 25 x 1 mL vials per carton, prescription only, manufactured by Hikma of Berkeley Heights, New Jersey, NDC 0641-6044-25, is being recalled. The action covers 382,775 1 mL vials.
The stated reason is failed impurities and degradation specifications: an out-of-specification result for total related compounds. The FDA classified the action as Class II. The source does not name the compounds or state a health consequence.
The affected lot is K24118, expiring 10/31/2026. Distribution was nationwide in the USA.
Facilities should identify affected stock using the NDC and lot number above and follow the instructions issued by Hikma.
The recalled product
- Product
- LORAZEPAM (LORAZEPAM)
- Brand
- LORAZEPAM
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injectable sedative
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 # K24118
- exp. date 10/31/2026
Distribution
Distributed nationwide across the United States.
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