Buprenorphine HCl Injection
Par Health is recalling Buprenorphine HCl Injection due to crystallization identified as Buprenorphine free base.
Contact your healthcare provider or pharmacy to arrange for the return or replacement of the affected product. Do not use the medication if crystallization is observed.
Why it was recalled
Par Health is recalling Buprenorphine HCl Injection due to the presence of crystallization, which has been identified as Buprenorphine free base. The affected product is a 0.3 mg/mL injection packaged in cartons containing five 1 mL single-dose vials.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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
- Recall #
- D-0596-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-18 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification