Nexterone — Class II drug recall D-0814-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-09-09, distributed nationwide. CGMP Deviations
| Recall number | D-0814-2026 |
|---|---|
| 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 | 43066-0150, 43066-0150-10, 43066-0360, 43066-0360-20 |
| Lot numbers | NC177832, NC185417, NC185455, NC188593, NC188647, NC188685, NC188807, NC188838, NC188920, NC193603, NC193726, NC193788, NC193863, NC193900, NC194082, NC194112, NC194143, NC195157 |
| Expiration dates | 2026-12-31, 2027-08-31, 2027-11-30, 2027-12-31, 2028-04-30, 2028-05-31 |
Product
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
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-0814-2026. 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.