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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98791

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

Open FDA event record

Event summary

Timeline bucket
April 24, 2026
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Lannett Company 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

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

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

D-0533-2026
Recall number
D-0533-2026
Initiated
April 24, 2026
Classification
Class III
Status
Ongoing
Recalling firm
Lannett Company Inc.
Quantity
44865 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Code information

Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.

Distribution pattern

USA Nationwide