Exact FDA event identifier

Event 97293

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

Event summary

Timeline bucket: July 21, 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

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30

D-0576-2025

Recall number: D-0576-2025
Initiated: July 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Ascend Laboratories, LLC
Quantity: 8,568 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: low dissolution results

Code information

Lot 23121560, Exp 4/30/2026

Distribution pattern

Nationwide in the USA