Buprenorphine recalls

The FDA has published 15 recalls involving Buprenorphine since 2013. The latest was reported on 9 Sep 2026. Cardinal Health has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls15since 2013

Last 12 months3reported

Class I00% of total

Ongoing4latest 9 Sep 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 1

Severity split

Class I 0 0%Class II 14 93%Class III 1 7%

Why buprenorphine is recalled

Companies

Brands

By year

2026320%
202417%
2023213%
202217%
2021320%
2020213%
201717%
201417%
201317%

Ongoing buprenorphine recalls

4 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
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 recalls, newest first

15 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
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
14 Jun 2023Drug	CLASS II	Buprenorphine Sublingual Tablets, 8 mg-bottles recalledBuprenorphine	Sun Pharmaceutical Industries	Manufacturing (CGMP) Deviations	Nationwide
9 Nov 2022Drug	CLASS II	Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg recalledBuprenorphine And Naloxone	Sun Pharmaceutical Industries	Other	Nationwide
14 Jul 2021Drug	CLASS II	Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled by AlvogenBuprenorphine And Naloxone	Alvogen	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Belbuca (buprenorphine hydrochloride) buccal film 600 mcg recalledBelbuca	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
2 Jun 2021Drug	CLASS II	Belbuca (buprenorphine hydrochloride) buccal film 300 mcg recalledBelbuca	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC

Should you stop taking Buprenorphine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.