June 2026 FDA Recall Buprenorphine Hydrochloride by Par Health Usa, Llc
D-0596-2026 - Crystallization; identified as Buprenorphine free base
This Class II drug recall was voluntarily initiated by Par Health Usa, Llc on June 12, 2026 for the product Buprenorphine Hydrochloride. The FDA reported the reason for recall as crystallization; identified as buprenorphine free base. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0596-2026
Crystallization; identified as Buprenorphine free base
06-12-2026
06-24-2026
46,334 units
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Par Health USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : 82886, exp 09/30/2026; 89646, exp 05/31/2027
