SPIRIVA HandiHaler — Class II drug recall D-0242-2018
Terminated recall by Boehringer Ingelheim Pharmaceuticals, Inc., reported 2018-02-07, distributed nationwide. Failed Stability Specifications
| Recall number | D-0242-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States |
| Recall initiated | 2017-12-14 |
| Classified | 2018-01-26 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2018-10-17 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00597-0075, 00597-0075-41, 00597-0075-47, 00597-0075-75 |
| Lot numbers | 03/18, 606478 |
Product
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
Reason for recall
Failed Stability Specifications
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-0242-2018. 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.