Class II

Drug Recall: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

ENDO USA, Inc. · March 13, 2026

Reason for Recall

Presence of particulate matter: identified as Buprenorphine free base

Distribution

USA Nationwide

States Affected

NATIONWIDE

Quantity Affected

34,293 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0527-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

ENDO USA, Inc. Drug Recall: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05. | SafeCheck