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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80961

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 04, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boehringer Ingelheim Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-1217-2018
Recall number
D-1217-2018
Initiated
September 04, 2018
Classification
Class II
Status
Terminated
Quantity
998 180-count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination With Other Products:

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination With Other Products:

Code information

Lot # 603968 EXP 4/2019

Distribution pattern

Nationwide