SPIRIVA HandiHaler — Class III drug recall D-1057-2013
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2013-09-25, distributed nationwide. Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign parti
| Recall number | D-1057-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2013-08-30 |
| Classified | 2013-09-16 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 15,385,232 capsules |
| NDC | 00597-0075, 00597-0075-27, 00597-0075-41, 00597-0075-47, 00597-0075-75 |
| Lot numbers | 202477A/SEP-13, 202480A/SEP-13, 202530/SEP-13, 202556A/SEP-13, 202556B/SEP-13, 202603A/SEP-13, 202784B/SEP-13, 202844A/SEP-13, 202951A/SEP-13, 203041A/SEP-13, 203042A, 203195A/OCT-13, 203280A/OCT-13, 203281A/OCT-13, 203364A/OCT-13, 203366C/NOV-13, 203440A, 203569A/OCT-13, 203569B/OCT-13, 203588A/OCT-13, 203660A/NOV-13, 203690A/NOV-13, 203890A/NOV-13, 203890B/NOV-13, 203980A/NOV-13, 203981A/NOV-13, 203981B/NOV-13, 204067A/NOV-13, 204094A/NOV-13, 204356B/DEC-13, 204357A/DEC-13, 204459A/DEC-13, 204460B/DEC-13, 204551A/DEC-13, 204552C/DEC-13, 204674A/DEC-13, 204821A/DEC-13, 204822A/DEC-13, 204944A/JAN-14, 204947A/JAN-14 and 47 more |
Product
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany
Reason for recall
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1057-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.