FDA Drug recall D-0128-2019
Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefi…
- FDA Drug
- Class II
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class II recall of Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefi… by Boehringer Ingelheim Pharmaceuticals, citing failed Dissolution Specifications: OOS resultsduring routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0128-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-22 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Boehringer Ingelheim Pharmaceuticals |
| Distribution | US |
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
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Identifiers
| code_info | Lot: 757739, EXP 9/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0128-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.