Buprenorphine recalls

Buprenorphine products have been recalled 3 times, most recently on 9 Sep 2026. The recalling company is usually American Health Packaging. The most common reason is potency & assay.

Total recalls3since 2020

Last 12 months1reported

Class I00% of total

Ongoing1latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 0 0%Class II 2 67%Class III 1 33%

Why buprenorphine is recalled

Companies

Product types

Creams, Ointments & Gels133%

By year

2026133%
2023133%
2020133%

Ongoing buprenorphine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS III	Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine	American Health Packaging	Packaging Defects	Nationwide

All buprenorphine recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS III	Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine	American Health Packaging	Packaging Defects	Nationwide
14 Jun 2023Drug	CLASS II	Buprenorphine Sublingual Tablets, 8 mg-bottles recalledBuprenorphine	SUN Pharmaceutical Industries	Manufacturing (CGMP) Deviations	Nationwide
7 Oct 2020Drug	CLASS II	Buprenorphine Transdermal System 5 mcg/hour recalledBuprenorphine	Teva Pharmaceuticals USA	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.