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

FDA recall notice · announced June 24, 2026 · Par Health

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

Crystallization; identified as Buprenorphine free base

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Quantity: 46,334 units
Status: Ongoing
Products in this recall event:
- 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 (D-0596-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.