FDA recall D-0596-2026

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 for recall

Crystallization; identified as Buprenorphine free base

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2026-06-12

Report date

2026-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0596-2026