Endo Usa, Inc.: Buprenorphine Hydrochloride, Injection, 0.3mg/ml, 5x1 Ml Single Dose Vials

Recalling firm
ENDO USA, Inc.
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
Presence of particulate matter: identified as Buprenorphine free base
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-03-13
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/9931296f-21b8-4aed-adbe-eeba3e2b97d7