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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96953

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

Open FDA event record

Event summary

Timeline bucket
May 28, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Apotex Corp.

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

Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4

D-0457-2025
Recall number
D-0457-2025
Initiated
May 28, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Apotex Corp.
Quantity
20,648 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

Code information

Batch # TZ5589, Exp Date: 01/31/2026

Distribution pattern

US Nationwide.