Has Boehringer Ingelheim Pharmaceuticals, Inc. had product recalls?

Yes, 2 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Boehringer Ingelheim Pharmaceuticals, Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Boehringer Ingelheim Pharmaceuticals, Inc. had?

Argus HQ has recorded 1 FDA events for Boehringer Ingelheim Pharmaceuticals, Inc.: 0 warning letters, 1 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Boehringer Ingelheim Pharmaceuticals, Inc.?

The most recent FDA event Argus HQ has on file for Boehringer Ingelheim Pharmaceuticals, Inc. is dated 2026-07-08, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Boehringer Ingelheim Pharmaceuticals, Inc.'s Complete FDA Record

FDA action counts

Total FDA actions	2
Warning letters	0
Recalls	2
Approval records	0
Form 483 inspection citations	0
Most recent action	July 8, 2026

Key takeaway: Argus HQ has recorded 1 FDA events for Boehringer Ingelheim Pharmaceuticals, Inc.: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-07-08 to 2026-07-08. The most severe rating Argus HQ has assigned across this history is "high". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Boehringer Ingelheim Pharmaceuticals, Inc. has 1 FDA event on file. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2026-07-08, Argus HQ recorded an FDA recall for Boehringer Ingelheim Pharmaceuticals, Inc., rated "high" severity in Argus HQ's classification: Boehringer Ingelheim Pharmaceuticals, Inc. — Class II recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

Has Boehringer Ingelheim Pharmaceuticals, Inc. had product recalls?: Yes, 2 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Boehringer Ingelheim Pharmaceuticals, Inc. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Boehringer Ingelheim Pharmaceuticals, Inc. had?: Argus HQ has recorded 1 FDA events for Boehringer Ingelheim Pharmaceuticals, Inc.: 0 warning letters, 1 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against Boehringer Ingelheim Pharmaceuticals, Inc.?: The most recent FDA event Argus HQ has on file for Boehringer Ingelheim Pharmaceuticals, Inc. is dated 2026-07-08, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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

Verified from FDA.gov · Last updated: Jul 8, 2026

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.'s Complete FDA Record. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/boehringer-ingelheim-pharmaceuticals-inc

MLA

"Boehringer Ingelheim Pharmaceuticals, Inc.'s Complete FDA Record." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/boehringer-ingelheim-pharmaceuticals-inc.

Chicago

Argus HQ Research. "Boehringer Ingelheim Pharmaceuticals, Inc.'s Complete FDA Record." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/company/boehringer-ingelheim-pharmaceuticals-inc.

BibTeX

@misc{argushq_argushq_ai_company_boehringer_ingelheim_pharmaceuticals_inc_2026,
  title = {Boehringer Ingelheim Pharmaceuticals, Inc.'s Complete FDA Record},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/boehringer-ingelheim-pharmaceuticals-inc},
  note = {Accessed: August 29, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗