Medications & Supplements/Prescription Drugs

Nicardipine Hydrochloride Injection Recalled for Sterility Concerns

Agency Publication Date: May 1, 2025

Summary

American Regent, Inc. has recalled 37,026 cartons of Nicardipine Hydrochloride Injection, USP (25 mg/10 mL) because liquid was found leaking around the neck of the vials. This defect could compromise the sterility of the medication, which is an injectable drug used to treat high blood pressure. The recall includes vials manufactured for Civica, Inc. and American Regent, Inc. with various expiration dates through June 2026.

Risk

A leak in the vial neck can allow bacteria or other contaminants to enter the medication, resulting in a lack of sterility. Injecting a non-sterile drug can lead to serious, life-threatening infections or other severe health complications.

What You Should Do

This recall affects Nicardipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL) in 10 mL single-dose vials, labeled for both Civica, Inc. and American Regent, Inc.
Check your supply for NDC codes 72572-470-10, 72572-470-01, 0517-0735-10, or 0517-0735-01.
Check the lot numbers and expiration dates printed on the vial or carton. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately and quarantine all affected vials to prevent further use.
Contact American Regent, Inc. or your medical distributor directly to arrange for the return of the affected product.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vialby Civica, Inc.

Variants: 10 mL Single Dose Vial, Rx Only

Lot Numbers:

24025N0C0 (Exp 6/30/2025)

24115N0C0 (Exp 10/31/2025)

24116N0C0 (Exp 3/31/2026)

24160N0C0 (Exp 12/31/2025)

24217N0C0 (Exp 01/31/2026)

24288N0C0 (Exp 04/30/2026)

24331N0C0 (Exp 5/31/2026)

NDC:

72572-470-10

72572-470-01

Mfd by: American Regent, Inc., New Albany, OH 43064. Distributed as cartons of 10 x 10mL vials.

Product: niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vialby American Regent, Inc.

Variants: 10 mL Single Dose Vial, Rx Only

Lot Numbers:

24086N0C0 (Exp 7/31/2025)

24076N0C0 (Exp 8/31/2025)

24090N0C0 (Exp 8/31/2025)

25011N0C0 (Exp 6/30/2026)

NDC:

0517-0735-10

0517-0735-01

Shirley, NY 11967. Distributed as cartons of 10 x 10 mL vials.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96695

Status: Active

Manufacturer: American Regent, Inc.

Sold By: Wholesalers; Hospitals; Infusion Centers; Medical Distributors

Manufactured In: United States

Units Affected: 2 products (29,777 (cartons of 10 x 10mL vials); 7,249 (cartons of 10 x 10 mL vials))

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Nicardipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL) in 10 mL single-dose vials, labeled for both Civica, Inc. and American Regent, Inc.

Check your supply for NDC codes 72572-470-10, 72572-470-01, 0517-0735-10, or 0517-0735-01.

Check the lot numbers and expiration dates printed on the vial or carton. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately and quarantine all affected vials to prevent further use.

Contact American Regent, Inc. or your medical distributor directly to arrange for the return of the affected product.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Affected Products

Product: niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vialby Civica, Inc.

Variants: 10 mL Single Dose Vial, Rx Only

Lot Numbers:

24025N0C0 (Exp 6/30/2025)

24115N0C0 (Exp 10/31/2025)

24116N0C0 (Exp 3/31/2026)

24160N0C0 (Exp 12/31/2025)

24217N0C0 (Exp 01/31/2026)

24288N0C0 (Exp 04/30/2026)

24331N0C0 (Exp 5/31/2026)

NDC:

72572-470-10

72572-470-01

Mfd by: American Regent, Inc., New Albany, OH 43064. Distributed as cartons of 10 x 10mL vials.

Product: niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vialby American Regent, Inc.

Variants: 10 mL Single Dose Vial, Rx Only

Lot Numbers:

24086N0C0 (Exp 7/31/2025)

24076N0C0 (Exp 8/31/2025)

24090N0C0 (Exp 8/31/2025)

25011N0C0 (Exp 6/30/2026)

NDC:

0517-0735-10

0517-0735-01

Shirley, NY 11967. Distributed as cartons of 10 x 10 mL vials.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96695

Status: Active

Manufacturer: American Regent, Inc.

Sold By: Wholesalers; Hospitals; Infusion Centers; Medical Distributors

Manufactured In: United States

Units Affected: 2 products (29,777 (cartons of 10 x 10mL vials); 7,249 (cartons of 10 x 10 mL vials))

Distributed To: Nationwide