Two lots of a sedation drug were pulled nationwide over particles that can block a lung

Par Health has recalled two lots of dexmedetomidine HCl in 0.9% sodium chloride injection, an intravenous sedative used in intensive care, after finding particulate matter that the company identified as cellulose or stopper material. The affected lots are 87558, which expires in February 2027, and 88802, which expires in April 2027, both sold as the 400 mcg per 100 mL bag under NDC 42023-187-01. No adverse events have been reported to date.

The company announced the voluntary recall on September 18, 2026, and the FDA posted the notice on September 21. It applies at the hospital level, so the pharmacies and units that stocked the product, rather than patients at home, are the ones being asked to act.

Cellulose or stopper particles in an IV bag

The product is a ready-to-use premixed bag: 400 mcg of dexmedetomidine in 100 mL of 0.9 percent sodium chloride, a concentration of 4 mcg per mL, labeled for intravenous infusion and distributed by Par Pharmaceutical. The recall covers only this premixed presentation and only the two named lots, so other dexmedetomidine products and other Par Health lots fall outside the notice as posted, and pharmacists checking inventory need to read the lot number and the NDC together rather than relying on the drug name alone.

According to the recall notice posted on FDA’s site, the problem is the “presence of particulate matter identified as cellulose or stopper material.” Stopper material is the rubber or elastomer closure that seals a container; cellulose is plant fiber, and either one has no business floating in a solution meant to run straight into a vein.

The recalled product was distributed nationwide to wholesalers between May 13 and June 29, 2025. That puts the stock more than a year old at the time of the announcement, which is why the notice leans on expiration dates and lot numbers: hospital pharmacists have to match what is still on their shelves against two specific lots, and everything outside them is untouched by the action. Because the recall sits at the hospital level, the instruction runs down the supply chain from wholesalers and distributors to the pharmacies that dispense to intensive care units and operating rooms.

Pulmonary emboli and the risk statement

Par Health states that administering the contaminated product has “a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli, occlusions of other blood vessels, and/or inflammation of the walls of veins,” in its company release. A pulmonary embolism is a blockage in an artery of the lung. The National Heart, Lung, and Blood Institute describes the usual version as a blood clot that breaks loose and travels through the bloodstream to the lungs, where it restricts blood flow and oxygen delivery, and calls it a serious medical emergency whose common signs include shortness of breath, pain during deep breathing and a rapid heart rate. Untreated, the institute says, it can lead to death.

In the recall, the mechanism is foreign particles rather than a clot, but the logic is the same: anything solid large enough to lodge in the small vessels of the lung can obstruct them. The risk statement is a statement of probability, not a report of harm, and the company says it has received no reports of adverse events.

The patients who receive dexmedetomidine

Dexmedetomidine is described in its prescribing information as a relatively selective, centrally acting alpha2-adrenergic agonist with sedative properties. The FDA-approved label for Precedex, the brand-name version of the drug, lists two main uses: sedation of initially intubated and mechanically ventilated adults in intensive care, given as a continuous infusion not exceeding 24 hours, and sedation of non-intubated adults, and some children, undergoing surgical or diagnostic procedures. Both settings put the drug in a hospital pharmacy’s hands, which is the audience the recall is written for.

Wholesalers, distributors and hospital pharmacies are told to stop using and distributing the two lots immediately. Returns run through Inmar, Inc., which Par Health has engaged to handle the recall; it can be reached at 1-833-599-3197 from 9 a.m. to 5 p.m. Eastern, Monday through Friday, or at [email protected]. Clinicians who see a quality problem or an adverse reaction can report it through the FDA’s MedWatch program, which accepts voluntary reports of product quality issues and serious reactions.

The timeline is short. Par Health announced on September 18 and the FDA posted the notice three days later, on September 21, and the notice says the FDA has been notified. Nothing in the posted text describes a wider expansion of the recall beyond the two lots.

The notice leaves two facts open: how many bags remain unused across the country, and whether any patient received an affected bag during the 15 months between distribution and recall. Par Health reports none so far.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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