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.
What this means for you
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
- Hazard
- impurity-specification
- related-compounds
- out-of-specification
- class-ii
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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