Tiotropium Bromide recalls
The FDA has published 5 recalls involving Tiotropium Bromide since 2013. The latest was reported on 3 Jan 2024. Most were for manufacturing (cgmp) deviations. Boehringer Ingelheim Roxane 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 recalls5since 2013
Last 12 months0reported
Class I00% of total
Ongoing0latest 3 Jan 2024
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 60%Class III 2 40%
Why tiotropium bromide is recalled
Companies
By year
All tiotropium bromide recalls, newest first
5 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Spiriva Handihaler (tiotropium bromide inhalation powder) recalledSpiriva | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva | Boehringer Ingelheim Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS III | Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) recalledSpiriva | Boehringer Ingelheim Roxane | Particulate Matter | Nationwide |
Should you stop taking Tiotropium Bromide?
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.