Ridgefield, CT, United States
Boehringer Ingelheim Pharmaceuticals, Inc. recalls
8 recalls recorded since 2018, most recently on 12 June 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)1
Terminated or completed7
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 12 June 2026
- 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.
- Distribution
- OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0657-2026
- 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
Terminated Class II Drugs
- Recall started
- 9 March 2023
- Terminated
- 4 December 2023
- Reason
- Labeling: Label Mix-up
- Distribution
- Product was distributed nationwide within the United States and PR
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0468-2023
- 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 an
Terminated Class II Drugs
- Recall started
- 4 May 2021
- Terminated
- 14 October 2021
- Reason
- Subpotent Drug
- Distribution
- AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0600-2021
- 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
Terminated Class II Drugs
- Recall started
- 5 October 2020
- Terminated
- 29 September 2021
- Reason
- An extraneous peak was observed for dissolution testing.
- Distribution
- Distributed Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0051-2021, D-0052-2021, D-0053-2021
- 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
- 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
- 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
Terminated Class III Drugs
- Recall started
- 7 March 2019
- Terminated
- 11 September 2019
- Reason
- Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0991-2019
- 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, N
Terminated Class II Drugs
- Recall started
- 22 October 2018
- Terminated
- 3 April 2023
- Reason
- Failed Dissolution Specifications: OOS resultsduring routine stability testing
- Distribution
- Distributed nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0128-2019
- 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
Terminated Class II Drugs
- Recall started
- 4 September 2018
- Terminated
- 19 August 2019
- Reason
- Cross Contamination With Other Products:
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1217-2018
- 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: B
Terminated Class II Drugs
- Recall started
- 14 December 2017
- Terminated
- 17 October 2018
- Reason
- Failed Stability Specifications
- Distribution
- Distributed nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0242-2018
- 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,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.