The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0051-2021·Announced 2020-11-04

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.

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, 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
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 (6)

  • Lot # 761544
  • 859015
  • EXP Jan 2021
  • 861346
  • 956626
  • EXP Jan 2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

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