FDA DrugClass IINotable

FDA Recall: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured fo

Date: 2026-05-20

Brand: ENDO USA, Inc.

Category: Drug

FDA Class: Class II

Description

Presence of particulate matter: identified as Buprenorphine free base

Hazard

Presence of particulate matter: identified as Buprenorphine free base

Remedy

34,293 vials

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