CARDENE IV — Class II drug recall D-0813-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-09-09, distributed nationwide. CGMP Deviations
| Recall number | D-0813-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2026-08-06 |
| Classified | 2026-08-28 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL |
| Reason classes | cgmp |
| NDC | 43066-0009, 43066-0009-10, 43066-0016, 43066-0016-10 |
| Lot numbers | NC177818, NC188869 |
| Expiration dates | 2026-12-31, 2027-12-31 |
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.
Reason for recall
CGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0813-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.