Buprenorphine Hydrochloride recalls

Buprenorphine Hydrochloride products have been recalled 8 times, most recently on 7 Oct 2026. The recalling company is usually PAR Sterile Products.

Total recalls8since 2014

Last 12 months3reported

Class I00% of total

Ongoing4latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 1 1Jun 0 0 0Sep 1 0

Severity split

Class I 0 0%Class II 8 100%Class III 0 0%

Why buprenorphine hydrochloride is recalled

Companies

Product types

Injectable & IV Drugs8100%

By year

2026338%
2024113%
2023113%
2020113%
2017113%
2014113%

Ongoing buprenorphine hydrochloride recalls

4 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Buprenorphine Hydrochloride, Injection 0.3 mg/mL recalledBuprenorphine Hydrochloride	Par Health USA	Other	Nationwide
24 Jun 2026Drug	CLASS II	Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USABuprenorphine Hydrochloride	Par Health USA	Other	Nationwide
20 May 2026Drug	CLASS II	Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo UsaBuprenorphine Hydrochloride	Endo USA	Other	Nationwide
3 Jul 2024Drug	CLASS II	Buprenorphine Hydrochloride Injection recalled by PfizerBuprenorphine Hydrochloride	Pfizer	Sterility	Nationwide

All buprenorphine hydrochloride recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Buprenorphine Hydrochloride, Injection 0.3 mg/mL recalledBuprenorphine Hydrochloride	Par Health USA	Other	Nationwide
24 Jun 2026Drug	CLASS II	Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USABuprenorphine Hydrochloride	Par Health USA	Other	Nationwide
20 May 2026Drug	CLASS II	Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo UsaBuprenorphine Hydrochloride	Endo USA	Other	Nationwide
3 Jul 2024Drug	CLASS II	Buprenorphine Hydrochloride Injection recalled by PfizerBuprenorphine Hydrochloride	Pfizer	Sterility	Nationwide
15 Nov 2023Drug	CLASS II	Buprenorphine HCl, Injection, 0.3mg/mL recalled by PAR Sterile ProductsBuprenorphine Hydrochloride	PAR Sterile Products	Packaging Defects	Nationwide
2 Sep 2020Drug	CLASS II	Buprenorphine HCl Injection, 0.3 mg/mL vial recalledBuprenorphine Hydrochloride	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
17 May 2017Drug	CLASS II	Buprenorphine HCI Injection, 0.3 mg/mL Single Dose Vial recalledBuprenorphine Hydrochloride	PAR Sterile Products	Particulate Matter	Nationwide
1 Oct 2014Drug	CLASS II	Buprenorphine Hydrochloride Injection, CIII recalled by HospiraBuprenorphine Hydrochloride	Hospira	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.