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 Number: D-0527-2026
Firm: ENDO USA, Inc.
Classification: Class II
Status: Ongoing
Report Date: 20260520
Initiation Date: 20260313
Termination Date:
Reason for Recall
Crystallization; identified as Buprenorphine free base
Product 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.