Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Nicardipine Hydrochloride Injection Recalled by Mylan Institutional LLC Due to Subpotent Drug and Failed Impurities/Degradation Specifications

Date: January 23, 2015
Company: Mylan Institutional LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Institutional LLC directly.

Affected Products

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10

Quantity: 78,090 vials

Why Was This Recalled?

Subpotent Drug and Failed Impurities/Degradation Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Institutional LLC

Mylan Institutional LLC has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report