Boehringer Ingelheim Pharmaceuticals, Inc.

Pharmaceutical company10 products tracked

products tracked

271,920

total reports

recalls on record

61.6%

serious overall

Products

showing 10 of 10

Product	Approved	Reports ↓	Top signal	Recalls
tiotropium bromide —	2004	150,254	Incorrect route of drug administration	0
empagliflozin —	2014	69,331	Euglycaemic diabetic ketoacidosis	7
linagliptin —	2011	20,890	Blindness	2
tiotropium bromide inhalation spray —	—	10,745	Sleep disorder due to a general medical condition	0
afatinib —	2013	6,549	Egfr gene mutation	0
tiotropium bromide and olodaterol —	—	4,837	Chronic obstructive pulmonary disease	0
empagliflozin, metformin hydrochloride —	—	3,303	Euglycaemic diabetic ketoacidosis	0
empagliflozin and metformin hydrochloride —	—	2,719	Euglycaemic diabetic ketoacidosis	4
empagliflozin and linagliptin —	—	1,913	Euglycaemic diabetic ketoacidosis	1
tipranavir —	2005	1,379	Cloacal exstrophy	0

Recall history · 16 on record

Date	Class	Reason	Firm
Mar 9, 2023	II	Labeling: Label Mix-up	Boehringer Ingelheim Pharmaceuticals, Inc.
Jan 26, 2022	II	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.	CARDINAL HEALTHCARE
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Oct 5, 2020	II	An extraneous peak was observed for dissolution testing.	Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2020	II	An extraneous peak was observed for dissolution testing.	Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2020	II	An extraneous peak was observed for dissolution testing.	Boehringer Ingelheim Pharmaceuticals, Inc.
Mar 7, 2019	III	Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.	Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 22, 2018	II	Failed Dissolution Specifications: OOS resultsduring routine stability testing	Boehringer Ingelheim Pharmaceuticals, Inc.
Sep 4, 2018	II	Cross Contamination With Other Products:	Boehringer Ingelheim Pharmaceuticals, Inc.
Sep 22, 2017	III	Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.	Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 6, 2016	II	Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.	Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 6, 2016	II	Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.	Boehringer Ingelheim Pharmaceuticals, Inc.

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Boehringer Ingelheim Pharmaceuticals, Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.