Catapres — Class II drug recall D-0128-2019
Terminated recall by Boehringer Ingelheim Pharmaceuticals, Inc., reported 2018-11-07, distributed nationwide. Failed Dissolution Specifications: OOS resultsduring routine stability testing
| Recall number | D-0128-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States |
| Recall initiated | 2018-10-22 |
| Classified | 2018-11-01 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2023-04-03 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00597-0007-01 |
| Lot numbers | 757739 |
| Expiration dates | 2020-09 |
Product
Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
Reason for recall
Failed Dissolution Specifications: OOS resultsduring routine stability testing
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-0128-2019. 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.