CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Cardene IV (Nicardipine Hydrochloride) recalled by Baxter Healthcare
Baxter Healthcare is recalling Cardene IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in (0.2, distributed nationwide in the US. The recall was initiated on 6 Aug 2026 and the FDA has classified it as Class II.
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-0813-2026
- FDA event ID
- 99500
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Cardene Iv
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Aug 2026
- FDA classified
- 28 Aug 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Aug 2026 | Recall initiated by company | |
| 28 Aug 2026 | Classified by FDA | +22 days |
| 9 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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.
Where it was distributed
US Nationwide; Puerto Rico; and Chile.
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
Where was it sold?
US Nationwide; Puerto Rico; and Chile.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
16 other products · FDA event 99500This product is part of a recall event; the main page for the event is Clindamycin Injection USP in 5% Dextrose, 900 mg recalled.
More recalls from Baxter Healthcare
All 565| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Nicardipine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per Vial recalledNicardipine Hydrochloride | Eugia US | Potency & Assay | Nationwide |