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FDA · Drugs ·

Buprenorphine HCl recall

Par Health USA, LLC recalled Buprenorphine HCl on June 24, 2026 because of crystallization; identified as Buprenorphine free base. It was sold nationwide.

Why it was recalled

Crystallization; identified as Buprenorphine free base

What's recalled

Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05

Quantity: 46,334 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Par Health USA, LLC, Rochester, MI
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide in the USA.
Status
Ongoing
Recall number
D-0596-2026
Source
U.S. Food and Drug Administration

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