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Boehringer Ingelheim Pharmaceuticals Recalls
13 recalls on record · November 2, 2016 to July 8, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per B
Hazard: 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.
March 29, 2023DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) b
Hazard: Labeling: Label Mix-up
June 9, 2021DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: B
Hazard: Subpotent Drug
November 4, 2020DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharm
Hazard: An extraneous peak was observed for dissolution testing.
November 4, 2020DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharm
Hazard: An extraneous peak was observed for dissolution testing.
November 4, 2020DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharm
Hazard: An extraneous peak was observed for dissolution testing.
March 20, 2019DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distribute
Hazard: Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
November 7, 2018DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuti
Hazard: Failed Dissolution Specifications: OOS resultsduring routine stability testing
October 3, 2018DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: B
Hazard: Cross Contamination With Other Products:
February 7, 2018DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx
Hazard: Failed Stability Specifications
October 18, 2017DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceutic
Hazard: Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
November 2, 2016DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, N
Hazard: 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.
November 2, 2016DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceut
Hazard: 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.