Boehringer Ingelheim Pharmaceuticals, Inc.

Complete recall history across all FDA and CPSC categories — 12 total recalls

Boehringer Ingelheim Pharmaceuticals, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (12)

FDA drug safety enforcement actions by Boehringer Ingelheim Pharmaceuticals, Inc.

Date Product Reason Class
Mar 9, 2023 JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-01... Labeling: Label Mix-up Class II
May 4, 2021 Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx... Subpotent Drug Class II
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II
Mar 7, 2019 Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tabl... Failed Tablet/Capsule Specifications: identification of low weight tablets du... Class III
Oct 22, 2018 Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only,... Failed Dissolution Specifications: OOS resultsduring routine stability testing Class II
Sep 4, 2018 Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. R... Cross Contamination With Other Products: Class II
Dec 14, 2017 SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90... Failed Stability Specifications Class II
Sep 22, 2017 Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist.... Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is pa... Class III
Oct 6, 2016 DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane ... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in ... Class II
Oct 6, 2016 Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dis... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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