CLASS II Drug recall · Reported 4 Nov 2020 · FDA Enforcement Report
Catapres (clonidine hydrochloride, USP) 1 mg, tablet recalled
Boehringer Ingelheim Pharmaceuticals is recalling Catapres (clonidine hydrochloride, USP) 1 mg, tablet, distributed nationwide in the US. The recall was initiated on 5 Oct 2020 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-0051-2021
- FDA event ID
- 86527
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2020
- FDA classified
- 26 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 5 Oct 2020 | Recall initiated by company | |
| 26 Oct 2020 | Classified by FDA | +21 days |
| 4 Nov 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An extraneous peak was observed for dissolution testing.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
Where it was distributed
Distributed Nationwide in the USA and Puerto Rico
Questions about this recall
Is Catapres (clonidine hydrochloride, USP) 1 mg, tablet recalled?
Yes. Boehringer Ingelheim Pharmaceuticals recalled Catapres (clonidine hydrochloride, USP) 1 mg, tablet on 5 Oct 2020. The recall is Class II and its status is Terminated. Recall number D-0051-2021.
Why was it recalled?
An extraneous peak was observed for dissolution testing.
Which lots are affected?
Lot # 761544, 859015, EXP Jan 2021, 861346, 956626, EXP Jan 2022
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boehringer Ingelheim Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Synjardy XR Tablets (empagliflozin recalled by Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals | Manufacturing (CGMP) Deviations | OH |
| Drug | CLASS II | Jardiance (Empagliflozin) recalled by Boehringer IngelheimJardiance | Boehringer Ingelheim Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Micardis Tablets, (telmisartan Tablets) 80 mg per folding recalled | Boehringer Ingelheim Pharmaceuticals | Potency & Assay | 11 states |
| Drug | CLASS II | Catapres (clonidine hydrochloride, USP) 3 mg, tablet recalled | Boehringer Ingelheim Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Catapres (clonidine hydrochloride, USP) 2 mg, tablet recalled | Boehringer Ingelheim Pharmaceuticals | Foreign Material | Nationwide |