Lorazepam Injection Recalled Due to Manufacturing Control Deviations
Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL due to CGMP deviations. The firm ceased operations and could not continue required stability studies.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for CGMP deviations affecting a parenteral benzodiazepine due to incomplete stability testing. No illnesses or injuries have been reported, making this a theoretical risk-of-harm product situation, which meets the High severity criterion.
Plain-English summary
Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL in 1 mL vials, manufactured by Akorn, Inc. in Lake Forest, Illinois. The product was distributed nationwide in the USA and Puerto Rico. This is a Class II recall.
The recall has been issued due to Current Good Manufacturing Practice (CGMP) deviations. The recalling firm went out of business and was unable to continue the stability studies required to verify and maintain the product's integrity and safety throughout its shelf life.
The recalled product
- Product
- Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Injectable Benzodiazepine
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 (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 86 recalled by Akorn, 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.
See all 86 products in this recall →Related recalls
Same manufacturer · Akorn, Inc.
See all →- HighGuaifenesin Oral Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighAkorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
FDA (Drugs) · 2023-06-07
- HighFDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA (Drugs) · 2023-06-07
- HighTobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighMidazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues
FDA (Drugs) · 2023-06-07
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection
FDA (Drugs) · 2026-08-19
- ModerateShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19