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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66014

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

Open FDA event record

Event summary

Timeline bucket
August 17, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amneal Pharmaceuticals of New York, 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

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

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141

D-66014-001
Recall number
D-66014-001
Initiated
August 17, 2013
Classification
Class II
Status
Terminated
Quantity
895 - 1000 count bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed dissolution specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications; 18 month CRT

Code information

Batch/Lot HL50611, exp. 1/2014

Distribution pattern

IL, NH, NJ, NY, OH, RI, TN

Field note

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