ANNOUNCED ONGOING Drug recall · Reported 21 Sep 2026 · FDA company announcement, classification pending
Par Pharmaceutical Dexmedetomidine HCl recalled by Par Health
Par Health is recalling Par Pharmaceutical Dexmedetomidine HCl in 9% Sodium Chloride Injection 400 mcg/ (4, distributed nationwide in the US. The recall was initiated on 18 Sep 2026 and is listed as ongoing.
Recall details
- Recall number
- FDA-PR-73e8c5e8a9c4
- Recalling firm
- Par Health
- Brand
- Par Pharmaceutical
- Classification
- Pending
- Status
- Ongoing
- Recall initiated
- 18 Sep 2026
- Reported
- 21 Sep 2026
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Sep 2026 | Recall initiated by company | |
| 21 Sep 2026 | Published in enforcement report | +3 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter identified as cellulose or stopper material. ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose or stopper material. Administration of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting. To date, Par Health has not received any reports of adverse events related to this recall. Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) is formulated for intravenous infusion. The product is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting and for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Recalled product can be identified as follows and by labels at bottom of this document: Product Description NDC Lot Expiration Date Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion, Distributed by: Par Pharmaceutical42023-187-018755802/
Product as listed by the company
Par Pharmaceutical Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
Where it was distributed
Nationwide
Stores named: Online Retailers
Questions about this recall
Is Par Pharmaceutical Dexmedetomidine HCl in 9% Sodium Chloride Injection 400 mcg/ (4 recalled?
Yes. Par Health recalled Par Pharmaceutical Dexmedetomidine HCl in 9% Sodium Chloride Injection 400 mcg/ (4 on 18 Sep 2026. The recall is unclassified and its status is Ongoing. Recall number FDA-PR-73e8c5e8a9c4.
Why was it recalled?
Presence of particulate matter identified as cellulose or stopper material. ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose or stopper material. Administration of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting. To date, Par Health has not received any reports of adverse events related to this recall. Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) is formulated for intravenous infusion. The product is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting and for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Recalled product can be identified as follows and by labels at bottom of this document: Product Description NDC Lot Expiration Date Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion, Distributed by: Par Pharmaceutical42023-187-018755802/
Where was it sold?
Nationwide
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.
Read the official FDA notice · Source record retrieved 21 Sep 2026. This is a company announcement published by the FDA; the FDA has not yet classified the recall. The record is updated when the classification appears in the Enforcement Report. This page reports the record and gives no medical advice.