FDA recall D-0527-2026

ENDO USA, Inc. · Class II · drug

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

Presence of particulate matter: identified as Buprenorphine free base

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2026-03-13
Report date
2026-05-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rochester, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0527-2026