Catapres — Class II drug recall D-0053-2021
Terminated recall by Boehringer Ingelheim Pharmaceuticals, Inc., reported 2020-11-04, distributed nationwide. An extraneous peak was observed for dissolution testing.
| Recall number | D-0053-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States |
| Recall initiated | 2020-10-05 |
| Classified | 2020-10-26 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2021-09-29 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, specification failure |
| NDC | 00597-0011-01 |
| Lot numbers | 954953 |
| Expiration dates | 2022-01-20 |
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 for recall
An extraneous peak was observed for dissolution 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-0053-2021. 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.