Drug recall D-0596-2026

Class II Ongoing reported Jun 24, 2026

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

Reason for recall

Crystallization; identified as Buprenorphine free base

Lots and codes

Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027

Recall details

Recalling firm
Par Health USA, LLC, Rochester, MI
Quantity
46,334 units
Distribution
Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
June 12, 2026

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