FDAClass II · Drug · Recalled May 20, 2026

Buprenorphine Hydrochloride recall — ENDO USA, Inc.

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-0527-2026
Brand: ENDO USA
Classification: Class II
Units affected: 34,293 vials
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

Affected products

Buprenorphine Hydrochloride

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 #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Distribution: USA Nationwide
Firm notified the public via: Letter
FDA event ID: 98610
Recall initiated: March 13, 2026
FDA classified: May 11, 2026
FDA report date: May 20, 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.

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