D-0527-2026Class II

ENDO USA, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

ENDO USA, Inc.

Product type

Drug

Status

Ongoing

Report date

2026-05-20

Distribution

USA Nationwide

Firm state

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. 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. Open the enforcement explorer →