Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Neoral soft gelatin capsules (cyclosporine capsules Recalled by Novartis Pharmaceuticals Corporation Due to CGMP deviations: Out of specification results obtained during...

Date: September 16, 2022
Company: Novartis Pharmaceuticals Corporation
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Novartis Pharmaceuticals Corporation directly.

Affected Products

Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.

Quantity: 132,999 cartons

Why Was This Recalled?

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report