Par Health Usa, Llc: Buprenorphine Hcl, Ciii, Injection, 0.3 Mg/ml, 5 X

Buprenorphine Injection Recall Summary Par Health USA is recalling Buprenorphine HCl 0.3 mg/mL injection vials nationwide because the medication has crystallized and contains buprenorphine free base instead of the correct formulation. This Class II recall affects the product with NDC 42023-179-05, which is a prescription injection used for pain management and opioid addiction treatment. The recall was distributed across all U.S. states and the District of Columbia.

Recalling firm

Par Health USA, LLC

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

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-12

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide in the USA.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/145496a3-dcc5-459a-8756-639c7d25a225