Boehringer Ingelheim Recalls Catapres 0.1 mg Tablets Due to Testing Issue
Boehringer Ingelheim recalls specific lots of Catapres 0.1 mg tablets after an extraneous peak was observed during dissolution testing.
Recall notice
An extraneous peak was observed for dissolution testing.
Contact the company
What happened, in plain English
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling specific lots of Catapres (clonidine hydrochloride) 0.1 mg tablets because an extraneous peak was observed for dissolution testing. The recall affects 13,270 bottles distributed nationwide in the USA and Puerto Rico. No remedy or action steps are currently stated in the record. Read more at govinfonow.com/recall/36739-boehringer-ingelheim-recalls-catapres-0-1-mg-tablets-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/36739-boehringer-ingelheim-recalls-catapres-0-1-mg-tablets-due-to · Updated October 11, 2026 · FDA enforcement record: FDA #D-0051-2021
Cite this page
“Boehringer Ingelheim Recalls Catapres 0.1 mg Tablets Due to Testing Issue.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36739-boehringer-ingelheim-recalls-catapres-0-1-mg-tablets-due-to. Based on FDA recall #D-0051-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0051-2021%22&limit=1).
Why it’s dangerous
The recall was initiated because an extraneous peak was observed during dissolution testing of the medication. The record does not explain what this means for the drug's effectiveness or safety, nor does it describe any potential injury mechanism.
Who’s affected
Patients who have been prescribed Catapres 0.1 mg tablets from the specific lots listed below. The record does not specify which health conditions these patients are treating.
How to tell if you have this one
Check your bottle for the brand name Catapres, strength 0.1 mg, and a 100-count size. Look for NDC 0597-0006-01 and one of the following lot numbers with their expiration dates: Lot # 761544 (EXP Jan 2021), Lot # 859015 (EXP Jan 2021), Lot # 861346 (EXP Jan 2022), or Lot # 956626 (EXP Jan 2022).
- Brand
Boehringer Ingelheim- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distributed Nationwide in the USA and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0051-2021 | 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; Lot # 761544, 859015, EXP Jan 2021, 861346, 956626, EXP Jan 2022 | 13,270 bottles/100 tablets each |
| D-0052-2021 | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01; Lot # 861135, C34139, EXP Nov 2021 | N/A |
| D-0053-2021 | 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; Lot # 954953, EXP Jan 2022 | N/A |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0051-2021 (October 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0051-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.