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

Par Health USA, LLC: Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-17

DrugsSource: FDA (drug) · Date: 2026-10-07

Read the official notice at FDA (drug) →

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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
Par Health USA, LLC
Product
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
Reason / hazard
Crystallization
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide
Recall initiated
2026-09-08
Code info
Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027
Product quantity
154210 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Rochester
State
MI
Country
United States
Event id
99902
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