Home / Recalls / ENDO USA, Inc. / D-0527-2026

D-0527-2026 Class II Ongoing

Recalled by ENDO USA, Inc. — Rochester, MI

Recall Details

Product Type
Drugs
Report Date
May 20, 2026
Initiation Date
March 13, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,293 vials

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.

Reason for Recall

Crystallization; identified as Buprenorphine free base

Distribution Pattern

USA Nationwide

Code Information

Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027

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  • D-0179-2025 Class I — Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 table (November 18, 2024)