Buprenorphine HCl recall (Par Health USA, LLC)
DrugClass IIOngoing
Summary: Par Health USA, LLC is recalling 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: Crystallization; identified as Buprenorphine free base.
What is being recalled
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
Why
Crystallization; identified as Buprenorphine free base
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0596-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 12, 2026 |
| Reported | June 24, 2026 |
| Company | Par Health USA, LLC |
| Company location | Rochester, MI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 46,334 units |
More recalls from Par Health USA, LLC · all drug recalls · recalls from June 2026