Exact FDA event identifier

Event 97511

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

Event summary

Timeline bucket: August 28, 2025
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Ascend Laboratories, 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03

D-0645-2025

Recall number: D-0645-2025
Initiated: August 28, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Ascend Laboratories, LLC
Quantity: 2,256 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent drug

Code information

Lot #: 24144162, Exp. Date 09/2027

Distribution pattern

Nationwide in the USA.