Recall D-0527-2026

US Class II Ongoing · initiated 2026-03-13

Recalling firm

ENDO USA, Inc., MI

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 for recall

Crystallization; identified as Buprenorphine free base

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