Injectable Drug Recalled for Potential Sterility Issues Due to Product Leakage
American Regent is recalling Nicardipine Hydrochloride Injection because product leakage around vial necks could compromise sterility. The nationwide recall affects approximately 29,777 cartons; no illnesses have been reported.
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: FDA Class II recall of an intravenous injectable with confirmed product leakage that could result in loss of sterility assurance. No illnesses or injuries have been reported and the sterility compromise is theoretical, limiting the score to High.
Plain-English summary
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection, USP, 2.5 mg/mL in 10 mL single-dose vials. The intravenous medication is manufactured for Civica, Inc. and distributed nationwide. The recall involves approximately 29,777 cartons.
The recall was initiated because of product leakage around the vial neck, which could potentially result in a lack of sterility assurance. Injectable medications must remain sterile to ensure safety when administered intravenously.
The affected vials are identified by the following lot numbers with expiration dates: Lot 24025N0C0 (6/30/2025), Lot 24115N0C0 (10/31/2025), Lot 24116N0C0 (3/31/2026), Lot 24160N0C0 (12/31/2025), Lot 24217N0C0 (1/31/2026), Lot 24288N0C0 (4/30/2026), and Lot 24331N0C0 (5/31/2026). Product NDC numbers are 72572-470-01 (vial) and 72572-470-10 (carton).
No illnesses or adverse events have been reported in connection with this recall. Patients should not stop taking their medication without speaking to a healthcare provider. Contact your pharmacy or healthcare provider to determine if your current supply is from an affected lot.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Intravenous Injectable
- Hazard
- product-leakage
- sterility-compromise
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 (15)
- Lots
- expiry: Lot 24025N0C0
- 6/30/2025
- Lot 24115N0C0
- 10/31/2025
- Lot 24116N0C0
- 3/31/2026
- Lot 24160N0C0
- 12/31/2025
- Lot 24217N0C0
- 01/31/2026
- Lot 24288N0C0
- 04/30/2026
- Lot 24331N0C0
- 5/31/2026
Distribution
Distributed nationwide across the United States.
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