Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly
Boehringer Ingelheim is recalling specific lots of Catapres tablets because an extraneous peak was observed during dissolution testing.
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, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling Catapres (clonidine hydrochloride, USP) 0.3 mg tablets. The recall involves 100-count bottles, prescription only, with NDC 0597-0011-01. The specific lot affected is #954953, with an expiration date of January 2022.
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 any reported adverse health events. The product was distributed nationwide in the USA and Puerto Rico.
Consumers with this specific lot should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement. The source text does not provide specific instructions for disposal or return.
The recalled product
- Product
- 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
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (2)
- Lot # 954953
- 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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