Rochester, MI, United States
Par Health USA, LLC recalls
2 recalls recorded since 2018, most recently on 8 September 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 8 September 2026
- Reason
- Crystallization
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0876-2026
- Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
Ongoing Class II Drugs
- Recall started
- 12 June 2026
- Reason
- Crystallization; identified as Buprenorphine free base
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.