Baxter CARDENE IV nicardipine injection recalled for manufacturing quality deviations
Baxter Healthcare has recalled specific lots of CARDENE IV (nicardipine hydrochloride) injection due to deviations from manufacturing quality standards. The affected lots were distributed in the United States, Puerto Rico, and Chile.
From the FDA notice · Read the official notice ↗ · All Baxter recalls
What to do
- If your healthcare facility has received lots NC177818 (expires 12/31/2026) or NC188869 (expires 12/31/2027), stop using them immediately.
- Contact Baxter Healthcare or your supplier for return or replacement instructions.
- Consult your healthcare provider if you have questions about alternative treatments.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
- Sold in
- Nationwide
- Made for
- Adults
This recall covers 17 products — see all of them.
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 1 Baxter Pkwy, N/A, Deerfield, IL, United States
- Classification
- Class II
- Recall number
- D-0813-2026
In the FDA's words
- Description
- CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10. CGMP Deviations Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027. Distribution: US Nationwide; Puerto Rico; and Chile. Affected quantity: N/A
- Hazard
- CGMP Deviations
17 products in this recall
Baxter IV drug bags recalled for manufacturing quality issues
Baxter is recalling 17 intravenous (IV) drug products for manufacturing quality problems, called CGMP deviations, which are lapses in the required production standards. The products include vancomycin, daptomycin, clindamycin, famotidine, dexmedetomidine, vasopressin, pantoprazole, insulin, nicardipine, and amiodarone, plus the brand names Myxredlin, CARDENE IV, and Nexterone. They were distributed nationwide, in Puerto Rico, and in Chile, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Health…D-0805-2026 · N/A
- MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, ND…D-0806-2026 · N/A
- Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile N…D-0807-2026 · N/A
- Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare…D-0808-2026 · N/A
- Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Ba…D-0809-2026 · N/A
- Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Health…D-0810-2026 · N/A
- Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporat…D-0811-2026 · N/A
- Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter…D-0812-2026 · N/A
- CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Mark… (this page)D-0813-2026 · N/A
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Health…D-0814-2026 · N/A
- Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare…D-0815-2026 · N/A
- Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxt…D-0816-2026 · N/A
- Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Bax…D-0817-2026 · N/A
- Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Bax…D-0818-2026 · N/A
- Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporat…D-0819-2026 · N/A
- Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare…D-0820-2026 · N/A
- Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogeni…D-0821-2026 · N/A
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