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

Par Health USA is recalling Buprenorphine HCl 0.3 mg/mL injection vials (NDC 42023-179-05) distributed nationwide because the medication developed crystallization and was identified as containing buprenorphine free base instead of the correct form. This is a Class II recall affecting the injectable opioid medication used for pain management and opioid use disorder treatment. Healthcare providers and patients who have received or are using this product should be aware of the recall.

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/0ecd4094-c84f-46b0-a44c-bedc45a931da