Lorazepam Injection recall
FDA recall D-0551-2025 · initiated Jul 22, 2025
Hikma Pharmaceuticals USA Inc. recalled Lorazepam Injection in Jul 2025 — an FDA Class II recall (D-0551-2025) because Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 382,775 1mL vials
Details
- Product
- Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
- Recalling company
- Hikma Intl Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Jul 22, 2025
- FDA report date
- Aug 6, 2025
This recall is linked to a product we cover: Ativan →
Frequently asked
- Was Lorazepam Injection recalled?
- Hikma Pharmaceuticals USA Inc. recalled Lorazepam Injection in Jul 2025 — an FDA Class II recall (D-0551-2025) because Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lorazepam Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0551-2025 was: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
- Is a recalled Lorazepam Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lorazepam Injection are affected?
- Distributed: Distributed Nationwide in the USA. The recall covers these lots — Lot # K24118, exp. date 10/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0551-2025.