Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly
Boehringer Ingelheim is recalling Catapres tablets because an extraneous peak was observed during dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a testing anomaly (extraneous peak) without confirmed adverse health consequences, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling Catapres (clonidine hydrochloride, USP) 0.1 mg tablets. The recall was initiated after an extraneous peak was observed during dissolution testing. The affected product is distributed in 100-count bottles and is available by prescription only.
The recall covers 13,270 bottles of Catapres tablets. The specific lots affected are #761544, #859015, #861346, and #956626. These lots have expiration dates of January 2021 and January 2022. The product was distributed nationwide in the United States and in Puerto Rico.
Consumers and healthcare providers should stop using the affected Catapres tablets and contact their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot # 761544
- 859015
- EXP Jan 2021
- 861346
- 956626
- EXP Jan 2022
Distribution
Part of a larger recall action
This product is one of 3 recalled by Boehringer Ingelheim Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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