Recalling firm
Par Health USA, LLC
Product type
Drug
Status
Ongoing
Report date
2026-06-24
Distribution
Nationwide in the USA.
Firm state
MI
Product quantity
46,334 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Crystallization; identified as Buprenorphine free base
Product description
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
Code / lot info
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.