Dexmedetomidine Hydrochloride in 0 — Class II drug recall D-0810-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-09-09, distributed nationwide. CGMP Deviations
| Recall number | D-0810-2026 |
|---|---|
| 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 | 00338-9557-12 |
| Lot numbers | NC188654, NC188821, NC193658, NC193702 |
| Expiration dates | 2027-08-31, 2027-09-30, 2028-01-31 |
Product
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 Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.
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-0810-2026. 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.