Official recall notice

FDA DrugClass IINotable

Buprenorphine Hydrochloride Injection Recall (May 2026)

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

Recall date
2026-05-20
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Presence of particulate matter: identified as Buprenorphine free base

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Product description

Presence of particulate matter: identified as Buprenorphine free base

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