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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86740

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

Open FDA event record

Event summary

Timeline bucket
November 10, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
EYWA PHARMA 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

Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52

D-0109-2021
Recall number
D-0109-2021
Initiated
November 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
EYWA PHARMA INC
Quantity
5451 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign tablet

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.

Code information

Lot #: LEV5019021A, Exp 10/2021

Distribution pattern

USA Nationwide