FDAClass II · Drug · Recalled June 24, 2026

Buprenorphine HCl recall — Par Health USA, LLC

Hazard: Crystallization; identified as Buprenorphine free base

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0596-2026
Brand: Par Health USA
Classification: Class II
Units affected: 46,334 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Buprenorphine HCl

Companies & origin

Recalling firm location: Rochester, MI, United States
Firm address: 870 Parkdale Rd, 48307-1740

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Distribution: Nationwide in the USA.
Firm notified the public via: Letter
FDA event ID: 99237
Recall initiated: June 12, 2026
FDA classified: June 17, 2026
FDA report date: June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

Report a data error on this page