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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79957

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 24, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mylan 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

2 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 2

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01

D-0819-2018
Recall number
D-0819-2018
Initiated
April 24, 2018
Classification
Class II
Status
Terminated
Quantity
25,488 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure

Code information

Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019

Distribution pattern

Product was distributed throughout United States

drug · product 2 of 2

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01

D-0820-2018
Recall number
D-0820-2018
Initiated
April 24, 2018
Classification
Class II
Status
Terminated
Quantity
12,924 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure

Code information

Lot Numbers# 3083008 and 3086124, exp Jan 2019

Distribution pattern

Product was distributed throughout United States