Recall: D-0527-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-13Initiated

OngoingStatus

ENDO USA, Inc.Firm

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.

Reason

Crystallization; identified as Buprenorphine free base

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.