Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Failures
Boehringer Ingelheim is recalling specific bottles of Catapres tablets because routine stability testing revealed they failed to meet dissolution specifications.
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, which is a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct physical injury risk like a foreign object or contamination.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling 1,380 bottles of Catapres .2 (clonidine hydrochloride, USP) 0.2mg tablets. The recall involves 100-count bottles with Lot 757739 and an expiration date of 9/2020. The product is distributed by Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT, and was made in Germany.
The recall was initiated because the product failed to meet dissolution specifications during routine stability testing. Dissolution testing ensures that a tablet breaks down and releases the medication into the body at the expected rate. When this specification is not met, the medication may not work as intended.
The affected product was distributed nationwide in the USA and Puerto Rico. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
- 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: 757739
- EXP 9/2020
Distribution
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