Mylan Institutional Nicardipine Hydrochloride Injection Recall

Why it was recalled

Subpotent Drug and Failed Impurities/Degradation Specifications

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0413-2015
Classification: Class III
Status: Terminated
Recall initiated: Jan 23, 2015
FDA report date: Mar 25, 2015
Quantity: 78,090 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Mylan Institutional LLC

Original FDA data

Every field from FDA enforcement report D-0413-2015, exactly as published.

Show all FDA fields

City: Rockford
State: IL
Status: Terminated
Country: United States
Event ID: 70375
Address: 4901 Hiawatha Dr
Code information: Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15
Postal code: 61103-1287
Report date: Mar 25, 2015
Product type: Drugs
Recall number: D-0413-2015
Classification: Class III
Recalling firm: Mylan Institutional LLC
Product quantity: 78,090 vials
Termination date: Apr 11, 2016
Reason for recall: Subpotent Drug and Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide
Recall initiation date: Jan 23, 2015
Initial firm notification: Letter
Center classification date: Mar 16, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0413-2015, published Mar 25, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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