Warning
Par Health USA Recalls Buprenorphine HCl
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0596-2026Drug / Pharmaceutical
Par Health USA Recalls Buprenorphine HCl
Par Health USA, LLC · Class II — Moderate Risk
Product Description
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Reason for Recall
Crystallization; identified as Buprenorphine free base
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Par Health USA, LLC initiated the recall on June 12, 2026 affecting 46,334 units. Crystallization; identified as Buprenorphine free base. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Par Health USA, LLC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.