Boehringer Ingelheim Pharmaceuticals recalls
FDA enforcement reports naming Boehringer Ingelheim Pharmaceuticals, Inc. as the recalling firm.
- Recall reports
- 13
- Class I (serious)
- 0
- Most recent report
- Jul 8, 2026
- Jul 8, 2026Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets…Drug · Boehringer Ingelheim Pharmaceuticals, Inc.CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.Class II
- Mar 29, 2023JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and…Drug · Boehringer Ingelheim Pharmaceuticals, Inc.Labeling: Label Mix-upClass II
- Jun 9, 2021Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ctDrug · Boehringer Ingelheim Pharmaceuticals, Inc.Subpotent DrugClass II
- Nov 4, 2020Catapres (clonidine hydrochloride, USP) 0Drug · Boehringer Ingelheim Pharmaceuticals, Inc.An extraneous peak was observed for dissolution testing.Class II
- Nov 4, 2020Catapres (clonidine hydrochloride, USP) 0Drug · Boehringer Ingelheim Pharmaceuticals, Inc.An extraneous peak was observed for dissolution testing.Class II
- Nov 4, 2020Catapres (clonidine hydrochloride, USP) 0Drug · Boehringer Ingelheim Pharmaceuticals, Inc.An extraneous peak was observed for dissolution testing.Class II
- Mar 20, 2019Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per fo…Drug · Boehringer Ingelheim Pharmaceuticals, Inc.Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.Class III
- Nov 7, 2018CatapresDrug · Boehringer Ingelheim Pharmaceuticals, Inc.Failed Dissolution Specifications: OOS resultsduring routine stability testingClass II
- Oct 3, 2018Synjardy (empagliflozin and metformin hydrochloride) TabletsDrug · Boehringer Ingelheim Pharmaceuticals, Inc.Cross Contamination With Other Products:Class II
- Feb 7, 2018SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules…Drug · Boehringer Ingelheim Pharmaceuticals, Inc.Failed Stability SpecificationsClass II
- Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist
- Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist
- DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist
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