Class II · Moderate risk
Cardene IV
CGMP Deviations
Is Nicardipine recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Nicardipine (14 total). Check the affected lots below.
Most common reason: Sterility / contamination (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nicardipine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Nicardipine recalls in 2026
2 initiated in 2026, 14 in total — newest first
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
nICARdipine HCl
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
NICARdipine 25 mg in NS 250 mL EXCEL bag
Lack of sterility assurance.
Class II · Moderate risk
Nicardipine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Nicardipine HCl in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Nicardipine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class III · Low risk
Nicardipine Hydrochloride Injection
Subpotent Drug and Failed Impurities/Degradation Specifications
Class III · Low risk
Nicardipine Hydrochloride Injection 25 mg/10 mL
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
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