Class II · Moderate risk
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
CGMP Deviations
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion recall
Par Health announced this recall on Sep 18, 2026. FDA has not yet published its classification (Class I, II or III) for it; that usually follows within a few weeks, and this page will then point to the classified recall.
Why it was recalled
Presence of particulate matter identified as cellulose or stopper material
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables.
What was recalled
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
NDC in the announcement
42023-0187-01
Compare with the code on your package — the lot numbers are listed in FDA’s notice.
Drug: Dexmedetomidine
Product details
From the FDA NDC directory, for the product code in this announcement.
| Product | Strength | Form & route | Labeler |
|---|---|---|---|
| Dexmedetomidine Hydrochloride NDC 42023-0187 |
4 ug/mL | Injection, Solution Intravenous |
Par Health USA, LLC |
- Company
- Par Health
- Brand
- Par Pharmaceutical
- Company announcement
- Sep 18, 2026
- Posted by FDA
- Sep 21, 2026
Check your lot number. Firm-announced recalls are usually the serious ones. Find the lot number on your package and compare it with the lots listed in FDA’s notice; if it matches, do not use it and speak to your pharmacist or prescriber today. Do not stop a prescribed medication without advice.
Earlier Dexmedetomidine recalls
See all
Class II · Moderate risk
dexmedeTOMIDine HCl PF
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL
cGMP deviations: Temperature abuse
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.