Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 63323-0614-01 recalled?

Hydralazine Hydrochloride · 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-614-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-00)

Yes — this exact package was recalled

2 FDA recalls name the code 63323-0614-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Hydralazine Hydrochloride
Strength
HYDRALAZINE HYDROCHLORIDE 20 mg/mL
Form
Injection · Intramuscular, Intravenous
Labeler
Fresenius Kabi USA, LLC
Type
Human Prescription Drug
Product code
63323-0614

Recalls naming this package

Class II · Moderate risk

hydrALAZINE HYDROCHLORIDE INJECTION

Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.

Terminated Temperature excursion Mckesson Medical Surgical NDC 63323-614-01 D-0668-2017
Class III · Low risk

Hydralazine Hydrochloride Injection

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Terminated Stability / shelf life Fresenius Kabi USA, LLC NDC 63323-614-01 D-1327-2015

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler