Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim
Boehringer Ingelheim recalls Catapres .2 0.2mg 100-count bottles due to failed dissolution specifications in stability testing. No remedy provided in official notice.
Recall notice
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Contact the company & request your remedy
What happened, in plain English
Boehringer Ingelheim is recalling Catapres .2 (clonidine hydrochloride) 0.2mg 100-count bottles because they failed dissolution tests during stability testing. This could mean the medication doesn't work properly over time, but the recall does not include a remedy. Read more at govinfonow.com/recall/39478-catapres-2-0-2mg-bottles-recalled-for-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/39478-catapres-2-0-2mg-bottles-recalled-for-failed-dissolution-testing · Updated October 5, 2026 · FDA enforcement record: FDA #D-0128-2019
Cite this page
“Catapres .2 0.2mg bottles recalled for failed dissolution testing.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39478-catapres-2-0-2mg-bottles-recalled-for-failed-dissolution-testing. Based on FDA recall #D-0128-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0128-2019%22&limit=1).
Why it’s dangerous
The medication failed dissolution specifications during routine stability testing, meaning it may not release the active ingredient properly over time. This could lead to inconsistent dosing, but the recall does not specify if this causes serious harm.
Who’s affected
Prescription patients who have the specific 0.2mg 100-count bottles with NDC 0597-0007-01 and lot 757739 (expired 9/2020) are affected. Patients using this medication should check if they have the recalled batch.
How to tell if you have this one
Check for the NDC code 0597-0007-01 and lot number 757739 on the bottle label. The product was made in Germany and expires September 2020.
- Brand
Boehringer Ingelheim- Category
Drug
What to do — step by step
Check Your Medication
Look for the NDC code 0597-0007-01 and lot number 757739 on the bottle label to confirm if it's recalled.
Questions people ask
Is there a remedy for this recall?
The official recall notice does not provide a remedy.
What does 'failed dissolution specifications' mean?
It means the medication may not release the active ingredient properly over time, but the recall does not specify if this causes serious harm.
How can I check if I have the recalled product?
Check the NDC code 0597-0007-01 and lot number 757739 on the bottle label.
Contact Boehringer Ingelheim
We’ve drafted a message you can send Boehringer Ingelheim to request your refund or repair — edit it as you like.
Subject: Recall D-0128-2019 — Boehringer Ingelheim Boehringer Ingelheim Hello, I own a Boehringer Ingelheim that is covered by recall D-0128-2019 from Boehringer Ingelheim. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0128-2019 (October 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0128-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.