FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

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

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 23, 2026 at 11:04 PM UTC.

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