fda_recall · drug_recall · high

Boehringer Ingelheim Pharmaceuticals, Inc. — Class II recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release…

Event date
2026-07-08 00:00:00Z
Observed
2026-07-14 04:20:19Z
Source ID
D-0657-2026
Payload hash
d00be84415fa4fd2179e2736

Summary

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. Status: Ongoing.

Frequently asked questions

Has Boehringer Ingelheim Pharmaceuticals, Inc. had other FDA enforcement actions?
This is the only FDA action Argus HQ has on file for Boehringer Ingelheim Pharmaceuticals, Inc. as of 2026-07-14. Argus ingests new FDA enforcement records daily.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Boehringer Ingelheim Pharmaceuticals, Inc. — Class II recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-boehringer-ingelheim-pharmaceuticals-inc-d-0657-2026
MLA
"Boehringer Ingelheim Pharmaceuticals, Inc. — Class II recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-boehringer-ingelheim-pharmaceuticals-inc-d-0657-2026.
Chicago
Argus HQ Research. "Boehringer Ingelheim Pharmaceuticals, Inc. — Class II recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-boehringer-ingelheim-pharmaceuticals-inc-d-0657-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_boehringer_ingelheim_pharmaceuticals_inc_d_0657_2026_2026,
  title = {Boehringer Ingelheim Pharmaceuticals, Inc. — Class II recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-boehringer-ingelheim-pharmaceuticals-inc-d-0657-2026},
  note = {Accessed: July 14, 2026}
}

Informational only. Not legal, financial, or medical advice.