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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98623

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

Open FDA event record

Event summary

Timeline bucket
March 19, 2026
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Amneal Pharmaceuticals, 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

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

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.

D-0408-2026
Recall number
D-0408-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Quantity
29,542 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity
Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

Code information

Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.

Distribution pattern

Nationwide within the USA