Buprenorphine HCl Recall: Par Health USA Lot 82886/89646
The FDA is recalling Par Health USA, LLC Buprenorphine HCl injection (0.3 mg/mL, 5 x 1 mL single-dose vials per carton, Rx Only) distributed nationwide. The recall is due to crystallization and identification as Buprenorphine free base. Affected lots are 82886 (exp 09/30/2026) and 89646 (exp 05/31/2027), with about 46,334 units; it is manufactured for Endo USA, Malvern, PA and has NDC 42023-179-05.
| Brand | Par Health USA, LLC |
|---|---|
| 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 |
| Reason | Crystallization; identified as Buprenorphine free base |
| Severity | moderate |
| Units affected | 46334 |
| Distribution | Nationwide in the USA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use vials from Lot 82886 or Lot 89646.
- Contact your healthcare provider or pharmacist for disposal or replacement guidance.
- If you have the product, set it aside and follow the recall instructions from FDA or the manufacturer, and visit the FDA recall page for details.
How to identify the recalled item
| Lot / date codes | Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027 |
|---|---|
| Lot / date codes | Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Par Health USA, LLC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.