United StatesBuprenorphine HCl CIII injection, 0.3 mg/mL in cartons of 5 x 1 mL single‑dose vials (Rx only), manufactured for Endo USA, NDC 42023-179-05, lot 82886 (exp 09/30/2026) and lot 89646 (exp 05/31/2027), sold nationwide by Par Health USA. The product was recalled because of crystallization identified as buprenorphine free base.
What's being recalled
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
Recalling firm: Par Health USA, LLC, Rochester, MI, United States.
How to identify it
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
The hazard
Crystallization; identified as Buprenorphine free base
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)