Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Decitabine for Injection Recalled by InvaGen Pharmaceuticals, Inc. Due to Failed impurities/degradation specifications: Failure to water content and...

Date: March 5, 2018
Company: InvaGen Pharmaceuticals, Inc.
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 InvaGen Pharmaceuticals, Inc. directly.

Affected Products

Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37

Quantity: 3222 vials

Why Was This Recalled?

Failed impurities/degradation specifications: Failure to water content and impurity

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals, Inc. has 11 total recalls tracked by RecallDetector.

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