United StatesBuprenorphine Hydrochloride injection, 0.3 mg/mL, 5x1 mL single‑dose vials (NDC 42023-179-05), lots 84132 (exp. 02/28/2027) and 87693 (exp. 03/31/2027) manufactured for ENDO USA, Malvern, PA. The product is being recalled nationwide in the U.S. because crystallization was found, identified as buprenorphine free base.
What's being recalled
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Recalling firm: ENDO USA, Inc., Rochester, MI, United States.
How to identify it
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
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
USA Nationwide
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)