Buprenorphine Recall: Endo Rx Only
FDA is recalling Par Health USA, LLC Buprenorphine Hydrochloride Injection 0.3 mg/mL, Rx Only, 5 x 1 mL single-dose vials manufactured for Endo USA, Malvern, PA. The recall is due to crystallization and affects about 154,210 bottles distributed nationwide. Recalled lots and expiration dates are Lot 83912 (10/2026), Lot 84234 (11/2026), Lot 84990 (11/2026), Lot 85003 (12/2026), Lot 86443 (01/2027), and Lot 89909 (05/2027); corrective action is not specified.
| Brand | Par Health USA, LLC |
|---|---|
| Product | 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 |
| Reason | Crystallization |
| Severity | moderate |
| Units affected | 154210 |
| Distribution | U.S. Nationwide |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use products from recalled lots.
- Check your vial's lot number and expiration date against the recalled lots; if matched, stop using and follow instructions from your healthcare provider or supplier for return or replacement.
- Contact the manufacturer or distributor for disposal or replacement instructions and report any adverse events to the FDA MedWatch program.
How to identify the recalled item
| Lot / date codes | Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027 |
|---|---|
| Lot / date codes | Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027 |
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.