Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim
Boehringer Ingelheim recalls Catapres 0.1 mg tablets due to dissolution testing anomalies. Affected lots from Jan 2021-2022; check NDC 0597-0006-01 for details.
Recall notice
An extraneous peak was observed for dissolution testing.
Contact the company & request your remedy
What happened, in plain English
Boehringer Ingelheim is recalling Catapres 0.1 mg tablets because dissolution testing showed an extraneous peak. This could affect medication consistency, but no injuries or specific remedy are mentioned in the recall. Read more at govinfonow.com/recall/36739-catapres-0-1-mg-tablets-recall-dissolution-testing-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/36739-catapres-0-1-mg-tablets-recall-dissolution-testing-issue · Updated October 4, 2026 · FDA enforcement record: FDA #D-0051-2021
Cite this page
“Catapres 0.1 mg tablets recall: Dissolution testing issue.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36739-catapres-0-1-mg-tablets-recall-dissolution-testing-issue. 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
Dissolution testing detected an unexpected peak, which may indicate inconsistent drug release. This could lead to variable medication effectiveness, but the recall does not specify injury risks or how it affects users.
Who’s affected
Prescription users of Catapres 0.1 mg tablets with NDC 0597-0006-01. People taking blood pressure medication are most at risk if they use the recalled product.
How to tell if you have this one
Check for NDC 0597-0006-01 on the bottle label. The product was made in Germany with specific lot numbers (761544, 859015, 861346, 956626) and expired by January 2021 or 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 |
What to do — step by step
Check Product Label
Look for NDC 0597-0006-01 on the bottle label to confirm if it's affected.
Questions people ask
Is this recall dangerous?
The recall mentions an extraneous peak in dissolution testing but does not state any injury risks or specific hazards.
What should I do if I have this product?
The recall does not provide a remedy, so no action is required beyond checking the product label.
Which lots are affected?
Affected lots include 761544, 859015, 861346, and 956626, with expiration dates of January 2021 or 2022.
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-0051-2021 — Boehringer Ingelheim Boehringer Ingelheim Hello, I own a Boehringer Ingelheim that is covered by recall D-0051-2021 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-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 qwen3:4b on October 4, 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.