FDAFDA · Food and drugs·Recall number D-0596-2026
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
Published June 24, 2026 · Recall initiated: June 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization; identified as Buprenorphine free base
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- Par Health USA, LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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