Buprenorphine Hydrochloride 0.324 mg per 1 mL injection

Where it's made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants ENDO USA, Inc. names for other drugs.

Recalls

• Sep 8, 2026 · Class II · Par Health USA, LLC
  Crystallization
  Lots: 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
• Jun 12, 2026 · Class II · Par Health USA, LLC
  Crystallization; identified as Buprenorphine free base
  Lots: Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
• Mar 13, 2026 · Class II · ENDO USA, Inc.
  Crystallization; identified as Buprenorphine free base
  Lots: Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
• Nov 9, 2021 · Class II · PAR Sterile Products LLC
  Crystallization; identified as Buprenorphine free base
  Lots: Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023
• Apr 28, 2017 · Class II · PAR Sterile Products LLC
  Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
  Lots: Lot #: 821102, 821103, Exp 01/18; 821104, 821106, 821107, Exp 02/18; 821108, Exp 03/18; 821884, 821885, Exp 07/18; 821886, 821887, Exp 08/18; 822767, Exp 09/18; 824183, Exp 10/18.

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Buprenorphine: every company that makes it

Form

injection, intramuscular; intravenous

Strength

0.324 mg per 1 mL

Approval

ANDA ANDA206586

On the market since

Jul 30, 2015

Package NDCs

42023-179-05

Official label

DailyMed (National Library of Medicine), updated Dec 18, 2025

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?