US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Jun 12, 2026 (3 months ago)

Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Crystallization; identified as Buprenorphine free base

What was 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

Recalling firm
Par Health USA, LLC
NDC code
42023-179-05
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0596-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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