CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Dexmedetomidine Hydrochloride recalled by Baxter Healthcare
Baxter Healthcare is recalling Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per (4 mcg/mL), 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-0810-2026
- FDA event ID
- 99500
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- 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
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.
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 # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.
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.
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| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
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| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
Other Dexmedetomidine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection recalled | Fresenius Kabi USA | Other | Nationwide |
| Drug | CLASS I | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection recalled | Fresenius Kabi USA | Other | Nationwide |
| Drug | CLASS II | Dexmedetomidine 400 mcg in NS, Made by: Enterprise Pharmacy recalled | CMC Enterprise Pharmacy | Sterility | NC |