Amerisource Health Services LLC — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-05-27, Argus HQ recorded a FDA recall for Amerisource Health Services LLC, rated "medium" severity in Argus HQ's classification: Amerisource Health Services LLC — Class III recall: Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per cart… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Amerisource Health Services LLC, rated "medium" severity in Argus HQ's classification: Amerisource Health Services LLC — Class III recall: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carto… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Amerisource Health Services LLC 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Amerisource Health Services LLC 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.

Frequently asked questions

Has Amerisource Health Services LLC had product recalls?

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

Is this FDA enforcement data for Amerisource Health Services LLC 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.

How many FDA actions has Amerisource Health Services LLC had?

Argus HQ has recorded 2 FDA events for Amerisource Health Services LLC: 0 warning letters, 2 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Amerisource Health Services LLC?

The most recent FDA event Argus HQ has on file for Amerisource Health Services LLC is dated 2026-05-27, with a severity rating of "medium" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Related enforcement actions

• Amerisource Health Services LLC — Class III recall: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carto… →
• Amerisource Health Services LLC — Class III recall: Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per cart… →

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