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OFFICIAL-SOURCE RECALL · UNITED STATES

Par Pharmaceutical Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 Recall: Presence of particulate

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CountryUnited StatesPublishedSeptember 21, 2026Last updatedSeptember 21, 2026Official source last checkedSeptember 28, 2026 at 7:38 PM UTC

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Is your product affected?

Brand
Par Pharmaceutical
Product
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
Manufacturer
Par Health
NDC
42023-187-01, 04/2027
Lot number
87558
Expiration date
02/2027
Package size
100 mL

The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.

Why this product was recalled

Presence of particulate matter identified as cellulose or stopper material

Hazard

Presence of particulate matter identified as cellulose or stopper material

Official recall notice

Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

Agency: U.S. Food & Drug Administration

Official publication date: September 21, 2026

Read the official FDA recall notice →

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