⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

ENDO USA, Inc.: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 4202

DrugsSource: FDA (drug) · Date: 2026-05-20

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
ENDO USA, Inc.
Product
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 / hazard
Crystallization; identified as Buprenorphine free base
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide
Recall initiated
2026-03-13
Code info
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Product quantity
34,293 vials
Voluntary mandated
Voluntary: Firm initiated
City
Rochester
State
MI
Country
United States
Event id
98610
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