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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93778

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

Open FDA event record

Event summary

Timeline bucket
December 26, 2023
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Amerisource Health Services 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

Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11

D-0257-2024
Recall number
D-0257-2024
Initiated
December 26, 2023
Classification
Class III
Status
Ongoing
Quantity
6,344 cartons

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: Assay results were slightly above specification at the time zero point.

Code information

Lot # 1014208, Exp Mar/31/2025

Distribution pattern

Nationwide in the USA