FDAHealthJune 12, 2026
Par Health USA, LLC — 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
⚠️ Crystallization; identified as Buprenorphine free base
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 12, 2026
Nationwide in the USA.
What's affected?
- 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
- Lot code
- 82886
Additional details
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 46,334 units.
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