Recalling firm
ENDO USA, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-05-20
Distribution
USA Nationwide
Firm state
MI
Product quantity
34,293 vials
Initiated by
Voluntary: Firm initiated
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.
Code / lot info
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.