CLASS II Drug recall · Reported 7 Nov 2018 · FDA Enforcement Report
Catapres .2 (clonidine hydrochloride, USP) 0.2mg recalled
Boehringer Ingelheim Pharmaceuticals is recalling Catapres .2 (clonidine hydrochloride, USP) 0.2mg, distributed nationwide in the US. The recall was initiated on 22 Oct 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0128-2019
- FDA event ID
- 81340
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2018
- FDA classified
- 1 Nov 2018
- Reported
- 7 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 22 Oct 2018 | Recall initiated by company | |
| 1 Nov 2018 | Classified by FDA | +10 days |
| 7 Nov 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Which lots are affected?
Lot: 757739, EXP 9/2020
Where was it sold?
Distributed nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.