Buprenorphine recalls
Buprenorphine products have been recalled 2 times, most recently on 14 Jun 2023. The recalling company is usually Teva Pharmaceuticals U. The most common reason is manufacturing (cgmp) deviations.
Total recalls2since 2020
Last 12 months0reported
Class I00% of total
Ongoing0latest 14 Jun 2023
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why buprenorphine is recalled
Companies
Product types
By year
All buprenorphine recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Buprenorphine Sublingual Tablets, 8 mg-bottles recalledBuprenorphine | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Buprenorphine Transdermal System 5 mcg/hour recalledBuprenorphine | Teva Pharmaceuticals U | 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.