Exact FDA event identifier

Event 96907

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

Event summary

Timeline bucket: May 22, 2025
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Aurobindo Pharma USA 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

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

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10

D-0471-2025

Recall number: D-0471-2025
Initiated: May 22, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Aurobindo Pharma USA Inc
Quantity: 4,608 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

Code information

Lot#: AEF124004A, Exp date 08/31/2026

Distribution pattern

USA Nationwide.