How many FDA warning letters has Hikma Pharmaceuticals USA INC received?

Argus HQ has not recorded an FDA warning letter for Hikma Pharmaceuticals USA INC in our current dataset.

What FDA recalls has Hikma Pharmaceuticals USA INC issued?

Argus HQ has recorded 1 FDA recall tied to Hikma Pharmaceuticals USA INC.

Is Hikma Pharmaceuticals USA INC FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 1 approval record for Hikma Pharmaceuticals USA INC. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

Hikma Pharmaceuticals USA INC

Name: FDA Enforcement Actions Against Hikma Pharmaceuticals USA 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_approval · anda2026-06-17
HIKMA — ANDA approval: SOLRIAMFETOL HYDROCHLORIDE (unspecified)
fda_recall · drug_recall2026-05-06
Hikma Pharmaceuticals USA INC — Class II recall: Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single…

Frequently asked questions

How many FDA warning letters has Hikma Pharmaceuticals USA INC received?: Argus HQ has not recorded an FDA warning letter for Hikma Pharmaceuticals USA INC in our current dataset.
What FDA recalls has Hikma Pharmaceuticals USA INC issued?: Argus HQ has recorded 1 FDA recall tied to Hikma Pharmaceuticals USA INC.
Is Hikma Pharmaceuticals USA INC FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 1 approval record for Hikma Pharmaceuticals USA 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.