Class II · ModerateActive recall
Buprenorphine Hydrochloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot#: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
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Crystallization
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byPar Health USA, LLC
| Brand name | BUPRENORPHINE HYDROCHLORIDE |
| Generic name | BUPRENORPHINE HYDROCHLORIDE |
| Active ingredient(s) | BUPRENORPHINE HYDROCHLORIDE |
| Distributed by / for | Endo USA, Malvern, PA |
| NDC | 42023-179-05 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Par Health USA, LLC |
| Distribution | U.S. Nationwide |
| Quantity | 154210 bottles |
| Recall initiated | 2026-09-08 |
| Report date | 2026-10-07 |
| Recall completed | — |
| Recall number | D-0876-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Rochester MI United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.