FDA Drug recall D-0053-2021
Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc by Boehringer Ingelheim Pharmaceuticals, citing an extraneous peak was observed for dissolution testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0053-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-05 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Boehringer Ingelheim Pharmaceuticals |
| Distribution | US |
Product
Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01
Reason
An extraneous peak was observed for dissolution testing.
Identifiers
| code_info | Lot # 954953, EXP Jan 2022 |
|---|
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-0053-2021%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.