ENDO USA, Inc. recalls Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern
Recalled May 20, 2026 · FDA recall D-0527-2026 · ENDO USA
Hazard
Crystallization; identified as Buprenorphine free base · FDA Class II
Units
34,293 vials
Sold at
USA Nationwide
Description
Crystallization; identified as Buprenorphine free base
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.
Manufacturer(s)
ENDO USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →