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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86527

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 05, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boehringer Ingelheim Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

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

D-0051-2021
Recall number
D-0051-2021
Initiated
October 05, 2020
Classification
Class II
Status
Terminated
Quantity
13,270 bottles/100 tablets each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An extraneous peak was observed for dissolution testing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

An extraneous peak was observed for dissolution testing.

Code information

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

Distribution pattern

Distributed Nationwide in the USA and Puerto Rico

drug · product 2 of 3

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

D-0052-2021
Recall number
D-0052-2021
Initiated
October 05, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An extraneous peak was observed for dissolution testing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

An extraneous peak was observed for dissolution testing.

Code information

Lot # 861135, C34139, EXP Nov 2021

Distribution pattern

Distributed Nationwide in the USA and Puerto Rico

drug · product 3 of 3

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

D-0053-2021
Recall number
D-0053-2021
Initiated
October 05, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An extraneous peak was observed for dissolution testing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

An extraneous peak was observed for dissolution testing.

Code information

Lot # 954953, EXP Jan 2022

Distribution pattern

Distributed Nationwide in the USA and Puerto Rico