FDA Recall
Ongoing
2026 recordClass II
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- 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.
- Published
- July 8, 2026
- Distribution
- OH
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FDA Recall
Terminated
Historical recordClass II
JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Labeling: Label Mix-up
- Published
- March 29, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Subpotent Drug
- Published
- June 9, 2021
- Distribution
- AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA a…
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FDA Recall
Terminated
Historical recordClass II
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
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- An extraneous peak was observed for dissolution testing.
- Published
- November 4, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
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
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- An extraneous peak was observed for dissolution testing.
- Published
- November 4, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
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
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- An extraneous peak was observed for dissolution testing.
- Published
- November 4, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
- Published
- March 20, 2019
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications: OOS resultsduring routine stability testing
- Published
- November 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Cross Contamination With Other Products:
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Failed Stability Specifications
- Published
- February 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
- Published
- October 18, 2017
- Distribution
- CO and OH
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FDA Recall
Terminated
Historical recordClass II
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- 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.
- Published
- November 2, 2016
- Distribution
- Nationwide
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This page lists recalls that name Boehringer Ingelheim Pharmaceuticals, Inc. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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