The Recall Desk
SevereFDA (Drugs)·D-0398-2025·Announced 2025-05-07

Nicardipine Hydrochloride Injection Recalled for Potential Sterility Issues

American Regent, Inc. is recalling Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects multiple lots distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall with a sterility defect in an intravenous injection—a high-risk drug product where loss of sterility assurance could lead to serious infection or other adverse health consequences requiring intervention.

Plain-English summary

American Regent, Inc. is recalling Nicardipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), in 10 mL single-dose vials. The recall involves 29,777 cartons of 10 vials manufactured for Civica, Inc. and distributed nationwide in the USA.

The recall was initiated due to product leakage around the vial neck, which could potentially result in a lack of sterility assurance. This affects the following lots: Lot 24025N0C0 (expires 6/30/2025), Lot 24115N0C0 (expires 10/31/2025), Lot 24116N0C0 (expires 3/31/2026), Lot 24160N0C0 (expires 12/31/2025), Lot 24217N0C0 (expires 01/31/2026), Lot 24288N0C0 (expires 04/30/2026), and Lot 24331N0C0 (expires 5/31/2026).

Healthcare facilities and pharmacies that have received affected product should stop using it immediately and contact American Regent, Inc. for instructions on return or proper disposal. Healthcare providers should verify lot numbers against the recall list before administering this medication to patients.

The recalled product

Product
NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
Brand
NICARDIPINE HYDROCHLORIDE
Manufacturer
American Regent, Inc.
Category
Drug — Intravenous Injection
Hazard

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.

Part of a larger recall action

This product is one of 2 recalled by American Regent, 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 2 products in this recall →

Related recalls

Same brand · NICARDIPINE HYDROCHLORIDE

Same manufacturer · American Regent, Inc.

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Same hazard · sterility defect

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