Buprenorphine Hydrochloride recalls

Buprenorphine Hydrochloride products have been recalled 7 times, most recently on 24 Jun 2026. The recalling company is usually PAR Sterile Products.

Total recalls7since 2014

Last 12 months2reported

Class I00% of total

Ongoing3latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 1 0Jul 0 0

Severity split

Class I 0 0%Class II 7 100%Class III 0 0%

Why buprenorphine hydrochloride is recalled

Companies

Product types

Injectable & IV Drugs7100%

By year

2026229%
2024114%
2023114%
2020114%
2017114%
2014114%

Ongoing buprenorphine hydrochloride recalls

3 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Buprenorphine HCl, CIII, Injection, 3 mg/mL recalled by Par Health USABuprenorphine Hydrochloride	Par Health USA	Other	Nationwide
20 May 2026Drug	CLASS II	Buprenorphine Hydrochloride, Injection, 3mg/mL, mL Single Dose Vials recalledBuprenorphine 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

7 total

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