Buprenorphine recalls
The FDA has published 22 recalls involving Buprenorphine since 2013. The latest was reported on 9 Sep 2026. Most were for potency & assay. Teva Pharmaceuticals USA 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 recalls 22 since 2013
Last 12 months 3 reported
Class I 0 0% of total
Ongoing 5 latest 9 Sep 2026
Recalls per month, last 24 months click a bar for that month Severity split
0 0%19 86%3 14%
Why buprenorphine is recalled
Ongoing buprenorphine recalls 5 active
All buprenorphine recalls, newest first 22 total Reported Class Recall Company Reason Where 9 Sep 2026 Drug CLASS III Buprenorphine Sublingual Tablets (C-iii), 2 mg recalled Buprenorphine American Health Packaging Packaging Defects Nationwide 24 Jun 2026 Drug CLASS II Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USA Buprenorphine Hydrochloride Par Health USA Other Nationwide 20 May 2026 Drug CLASS II Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo Usa Buprenorphine Hydrochloride Endo USA Other Nationwide 3 Jul 2024 Drug CLASS II Buprenorphine Hydrochloride Injection recalled by Pfizer Buprenorphine Hydrochloride Pfizer Sterility Nationwide 15 Nov 2023 Drug CLASS II Buprenorphine HCl, Injection, 0.3mg/mL recalled by PAR Sterile Products Buprenorphine Hydrochloride PAR Sterile Products Packaging Defects Nationwide 14 Jun 2023 Drug CLASS II Buprenorphine Sublingual Tablets, 8 mg-bottles recalled Buprenorphine SUN Pharmaceutical Industries Manufacturing (CGMP) Deviations Nationwide 1 Feb 2023 Drug CLASS II Buprenorphine HCL 0.9 MG/ML vial) Injectable recalled Pharmacy Innovations Sterility Nationwide 9 Nov 2022 Drug CLASS II Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg recalled Buprenorphine And Naloxone SUN Pharmaceutical Industries Other Nationwide 14 Jul 2021 Drug CLASS II Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled by Alvogen Buprenorphine And Naloxone Alvogen Potency & Assay Nationwide 2 Jun 2021 Drug CLASS II Buprenorphine And Naloxone Sublingual Film 4mg/1mg recalled Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 2 Jun 2021 Drug CLASS II Belbuca (buprenorphine hydrochloride) buccal film 600 mcg recalled Belbuca Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 2 Jun 2021 Drug CLASS II Belbuca (buprenorphine hydrochloride) buccal film 300 mcg recalled Belbuca Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 7 Oct 2020 Drug CLASS II Buprenorphine Transdermal System 5 mcg/hour recalled Buprenorphine Teva Pharmaceuticals USA Potency & Assay Nationwide 2 Sep 2020 Drug CLASS II Buprenorphine HCl Injection, 0.3 mg/mL vial recalled Buprenorphine Hydrochloride Hikma Pharmaceuticals USA Potency & Assay Nationwide 26 Jul 2017 Drug CLASS III Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg recalled Teva Pharmaceuticals USA Potency & Assay Nationwide 26 Jul 2017 Drug CLASS III Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg recalled Teva Pharmaceuticals USA Potency & Assay Nationwide 17 May 2017 Drug CLASS II Buprenorphine HCI Injection, 0.3 mg/mL Single Dose Vial recalled Buprenorphine Hydrochloride PAR Sterile Products Particulate Matter Nationwide 22 Mar 2017 Drug CLASS II Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg HDPE recalled Teva Pharmaceuticals USA Potency & Assay Nationwide 5 Oct 2016 Drug CLASS II Buprenorphine, 0.6 mg/ml Injection MDV Sterile, Rx recalled Pharmacy Plus Sterility MS 1 Oct 2014 Drug CLASS II Buprenorphine Hydrochloride Injection, CIII recalled by Hospira Buprenorphine Hydrochloride Hospira Potency & Assay Nationwide 17 Jul 2013 Drug CLASS II Buprenorphine 0.3 mg/ml Injection recalled by Lowlite Investments Lowlite Investments Sterility Nationwide 22 May 2013 Drug CLASS II Buprenorphine Injection, all strengths recalled by FVS Holdings FVS Holdings Sterility Nationwide
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.