ANI Pharmaceuticals, Inc. — FDA Enforcement History

FDA action counts

Enforcement history

On 2026-05-27, Argus HQ recorded a FDA recall for ANI Pharmaceuticals, Inc., rated "high" severity in Argus HQ's classification: ANI Pharmaceuticals, Inc. — Class II recall: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only,… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for ANI Pharmaceuticals, Inc., rated "medium" severity in Argus HQ's classification: ANI Pharmaceuticals, Inc. — Class III recall: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, ANI Pharmaceuticals, 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. ANI Pharmaceuticals, 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 ANI Pharmaceuticals, 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 ANI Pharmaceuticals, Inc.?

July 1, 2026. Argus HQ ingests new FDA enforcement records daily.

Has ANI Pharmaceuticals, Inc. had product recalls?

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

Is this FDA enforcement data for ANI Pharmaceuticals, 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

• ANI Pharmaceuticals, Inc. — Class III recall: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on… →
• ANI Pharmaceuticals, Inc. — Class II recall: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only,… →

Compare with

• ANI Pharmaceuticals, Inc. vs Medline Industries, LP
• ANI Pharmaceuticals, Inc. vs ARROW INTERNATIONAL, LLC
• ANI Pharmaceuticals, Inc. vs Stryker Sustainability Solutions
• ANI Pharmaceuticals, Inc. vs Guardian Drug Co. Inc.
• ANI Pharmaceuticals, Inc. vs B BRAUN MEDICAL INC