Recall: D-0596-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-12Initiated

OngoingStatus

Par Health USA, LLCFirm

Product

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

Reason

Crystallization; identified as Buprenorphine free base

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.