BUPRENORPHINE HYDROCHLORIDE
Recalling Firm / Manufacturer: ENDO USA, Inc.
(Rochester, MI, United States)
FDA Recall Number: D-0527-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
BUPRENORPHINE HYDROCHLORIDE
Generic Name
BUPRENORPHINE HYDROCHLORIDE
Active Substance(s)
Buprenorphine Hydrochloride
Administration Route
Intramuscular
National Drug Code (NDC)
42023-179
Total Quantity Recalled
34,293 vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Crystallization; identified as Buprenorphine free base
Full Product Description
Packaging specifications and labeling details
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
May 20, 2026
Firm Initiation Date
March 13, 2026
FDA Classification Date
May 11, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Distribution Information
Geographic scope of affected shipments
USA Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0527-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508603UTCC