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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80397

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

Open FDA event record

Event summary

Timeline bucket
June 27, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Aidarex Pharmaceuticals LLC

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

3 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 3

Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

D-0990-2018
Recall number
D-0990-2018
Initiated
June 27, 2018
Classification
Class III
Status
Terminated
Quantity
11, 90-count bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Code information

Lots: 56698-1, EXP 1/31/2019; 56698-2, EXP 4/30/2019

Distribution pattern

Distributed Nationwide in the USA

drug · product 2 of 3

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

D-0991-2018
Recall number
D-0991-2018
Initiated
June 27, 2018
Classification
Class III
Status
Terminated
Quantity
61, 90-count bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Code information

Lots: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 53840-2,EXP: 5/28/2018; 53840-3, EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1, EXP: 01/31/2019; 58596-1, EXP: 05/28/2019.

Distribution pattern

Distributed Nationwide in the USA

drug · product 3 of 3

Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

D-0992-2018
Recall number
D-0992-2018
Initiated
June 27, 2018
Classification
Class III
Status
Terminated
Quantity
25, 30-count bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Code information

Lots: 51904-2, EXP: 01/31/2018; 51904-3, EXP: 02/28/2018; 51904-5, EXP: 03/31/2018; 52885-2, EXP: 03/31/2018, 53840-1, EXP: 5/28/2018.

Distribution pattern

Distributed Nationwide in the USA