How many FDA warning letters has ANI Pharmaceuticals, Inc. received?

Argus HQ has not recorded an FDA warning letter for ANI Pharmaceuticals, Inc. in our current dataset.

What FDA recalls has ANI Pharmaceuticals, Inc. issued?

Argus HQ has recorded 2 FDA recalls tied to ANI Pharmaceuticals, Inc..

Is ANI Pharmaceuticals, Inc. FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 2 recalls, and 0 approval records for ANI Pharmaceuticals, Inc.. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

ANI Pharmaceuticals, Inc.

Name: FDA Enforcement Actions Against ANI Pharmaceuticals, Inc.
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · drug_recall2026-07-01
ANI Pharmaceuticals, Inc. — Class III recall: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on…
fda_recall · drug_recall2026-05-27
ANI Pharmaceuticals, Inc. — Class II recall: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only,…

Frequently asked questions

How many FDA warning letters has ANI Pharmaceuticals, Inc. received?: Argus HQ has not recorded an FDA warning letter for ANI Pharmaceuticals, Inc. in our current dataset.
What FDA recalls has ANI Pharmaceuticals, Inc. issued?: Argus HQ has recorded 2 FDA recalls tied to ANI Pharmaceuticals, Inc..
Is ANI Pharmaceuticals, Inc. FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 2 recalls, and 0 approval records for ANI Pharmaceuticals, Inc.. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.