FDA Recall Alert: Par Pharmaceutical Dexmedetomidine HCl IV for Particulate Contamination
Par Pharmaceutical (marketed as Par Health) is voluntarily recalling two hospital lots of Dexmedetomidine HCl 400 mcg/100 mL IV infusion after internal quality checks found cellulose and rubber-stopper fragments in some vials. Infusing particulate-contaminated solutions can precipitate pulmonary emboli, vascular occlusion, or other life-threatening events. Healthcare facilities must quarantine lots 87558 and 88802 immediately and arrange product returns.
Par Pharmaceutical Dexmedetomidine Recall — Quick Facts
- Product name: Dexmedetomidine HCl in 0.9 % Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL)
- Manufacturer / Distributor: Par Pharmaceutical, Inc. (Par Health)
- NDC: 42023-187-01
- Affected lots & expiry: 87558 (02/2027) | 88802 (04/2027)
- U.S. distribution window: 13 May 2026 – 29 Jun 2026 (nationwide)
- Recall reason: Visible particulate matter (cellulose or stopper fragments)
- Required action: Stop use, isolate inventory, and contact Inmar at 1-833-599-3197 for returns/credit
Sources
Health Risks of Particulate-Contaminated Dexmedetomidine
When particles enter the bloodstream, they can migrate to the lungs or peripheral organs, blocking blood flow, provoking inflammation, and initiating clot formation. Although no injuries have been reported to date, the FDA considers the threat of severe harm “reasonable.” Rapid removal of affected stock protects patients and limits liability.
Immediate Actions for Hospitals & Pharmacists
- Locate all Dexmedetomidine HCl 400 mcg/100 mL inventory and verify lot numbers 87558 and 88802.
- Segregate any matching vials; halt dispensing, administration, and further distribution.
- Contact Inmar, Inc. at 1-833-599-3197 (Mon–Fri 9 a.m.–5 p.m. ET) or email rxrecalls@inmar.com for prepaid return labels and credit processing.
- Alert downstream facilities, satellite pharmacies, and anesthesia teams that may possess the recalled product.
- Report adverse events to FDA MedWatch online (fda.gov/MedWatch/report.htm) or by downloading Form 3500 (fda.gov/MedWatch/getforms.htm).
Official Recall Images
Par Pharmaceutical Recall Contacts
Returns & Logistics: Inmar, Inc. • 1-833-599-3197 • rxrecalls@inmar.com
Medical/Technical Inquiries: 1-800-828-9393 (Mon–Thu 9 a.m.–8 p.m., Fri 9 a.m.–6 p.m. ET)
Frequently Asked Questions
Is my Par Pharmaceutical Dexmedetomidine vial included in the recall?
Only vials printed with lot numbers 87558 or 88802 (NDC 42023-187-01) are affected. Confirm the lot on the overwrap or primary container.
What should I do with recalled Par Pharmaceutical Dexmedetomidine HCl?
Immediately quarantine the product, discontinue clinical use, and contact Inmar at 1-833-599-3197 for return kits and reimbursement.
Why are particles dangerous in an IV sedative such as Par Pharmaceutical Dexmedetomidine?
Particles may embolize, obstructing pulmonary or peripheral vasculature, which can lead to hypoxia, tissue infarction, or multi-organ damage.
Have any injuries been reported from the recalled lots?
No adverse events were reported as of 21 September 2026; the recall is precautionary to prevent potential harm.
Can clinicians report side effects from Par Pharmaceutical Dexmedetomidine directly to the FDA?
Yes. Use the FDA MedWatch portal or Form 3500 to report any suspected adverse reactions or quality problems.
Does the recall include generic or compounded alternatives?
No. The recall is limited to Par-labeled vials with lot numbers 87558 and 88802. Other manufacturers’ or compounders’ products are not involved.
How can hospitals replace inventory lost to the recall?
Contact your group purchasing organization (GPO) or primary wholesaler for substitute sedatives, or order unaffected Dexmedetomidine lots once Par Pharmaceutical resumes distribution.