CLASS III Drug recall · Reported 25 Mar 2015 · FDA Enforcement Report
Nicardipine Hydrochloride Injection, 25 mg recalled
Mylan Institutional is recalling Nicardipine Hydrochloride Injection, 25 mg/ (2.5 mg/mL) single dose vial, distributed nationwide in the US. The recall was initiated on 23 Jan 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0413-2015
- FDA event ID
- 70375
- Recalling firm
- Mylan Institutional, Rockford, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Jan 2015
- FDA classified
- 16 Mar 2015
- Reported
- 25 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Jan 2015 | Recall initiated by company | |
| 16 Mar 2015 | Classified by FDA | +52 days |
| 25 Mar 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug and Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug and Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
Other Nicardipine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene Iv | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) recalledNicardipine Hydrochloride | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | UT |