Reported Oct 7, 2026 · Ongoing · Updated Oct 27, 2026
Dexmedetomidine HCL in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4mcg/mL), Rx Only, 10x100 mL Single-Dose Vials…
Par Health USA, LLC
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Par Health USA, LLC · 870 Parkdale Rd · Rochester, MI · 48307-1740
Is this the product you have?
- Dexmedetomidine HCL in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4mcg/mL), Rx Only, 10x100 mL Single-Dose Vials per carton
- Manufactured forEndo USA, Malvern, PA 19355
- CartonNDC 42023-187-10
- Vial NDC42023-187-01
- Lot codes and dates
- Lot #: 87558
- Exp
02/28/202788802
- Exp04/30/2027
- Amount recalled
- 773 10x100ml vials per carton
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: the particulate was identified as cellulose or stopper material
The agency has not ranked the risk yet — treat the notice as a caution.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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