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Par Health USA, LLC recalls Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intr

Recalled June 24, 2026 · FDA recall D-0596-2026 · Par Health USA

Hazard
Crystallization; identified as Buprenorphine free base · FDA Class II
Units
46,334 units
Sold at
Nationwide in the USA.

Description

Crystallization; identified as Buprenorphine free base

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
Manufacturer(s)
Par Health USA, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Par Health USA, LLC recalls Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intr | RecallWatchUSA