Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc. appears in FDA public data with 13 recalls, 2 510(k) clearances, 16 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0657-2026, Class II) was initiated on June 12, 2026. Its most recent 510(k) clearance was granted on October 15, 1986.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 2
- Inspections
- 16
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0657-2026 | Class II | Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 | June 12, 2026 |
| D-0468-2023 | Class II | JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count | March 9, 2023 |
| D-0600-2021 | Class II | Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37 | May 4, 2021 |
| D-0053-2021 | Class II | Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehri | October 5, 2020 |
| D-0052-2021 | Class II | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehri | October 5, 2020 |
| D-0051-2021 | Class II | Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehri | October 5, 2020 |
| D-0991-2019 | Class III | Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, | March 7, 2019 |
| D-0128-2019 | Class II | Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer I | October 22, 2018 |
| D-1217-2018 | Class II | Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottl | September 4, 2018 |
| D-0242-2018 | Class II | SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose bl | December 14, 2017 |
| D-0007-2018 | Class III | Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelhe | September 22, 2017 |
| D-0114-2017 | Class II | DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Col | October 6, 2016 |
| D-0113-2017 | Class II | Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingel | October 6, 2016 |