Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly
Boehringer Ingelheim is recalling specific Catapres tablets because an extraneous peak was observed during dissolution testing. The recall covers products distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the source text does not report any illnesses or injuries. The hazard is a testing anomaly without confirmed harm, fitting the criteria for a moderate severity score.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling Catapres (clonidine hydrochloride, USP) 0.2 mg tablets. The recall is limited to 100-count bottles with NDC 0597-0007-01, Lot # 861135, C34139, and an expiration date of November 2021.
The recall was initiated because an extraneous peak was observed during dissolution testing. The source text does not specify the nature of the peak or the potential clinical impact. The affected products were distributed nationwide in the USA and Puerto Rico.
Consumers and healthcare providers should check their inventory for the specific lot and expiration date listed above. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the product.
The recalled product
- Product
- 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
- 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 (3)
- Lot # 861135
- C34139
- EXP Nov 2021
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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