Lannett Company Inc. — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-05-27, Argus HQ recorded a FDA recall for Lannett Company Inc., rated "medium" severity in Argus HQ's classification: Lannett Company Inc. — Class III recall: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-10, Argus HQ recorded a FDA recall for Lannett Company Inc., rated "high" severity in Argus HQ's classification: Lannett Company Inc. — Class II recall: Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distr… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Lannett Company Inc. has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Counting an FDA record here does not by itself indicate an unresolved problem -- warning letters, recalls, and inspection observations are frequently closed out once a firm completes FDA-required corrective action.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Lannett Company Inc. has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Frequently asked questions

How many FDA actions does Argus HQ track for Lannett Company Inc.?

2 total: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Lannett Company Inc.?

June 10, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Lannett Company Inc. had product recalls?

Yes, 2 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Lannett Company Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

Related enforcement actions

• Lannett Company Inc. — Class II recall: Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distr… →
• Lannett Company Inc. — Class III recall: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett… →

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