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.

Risperdal CONSTA (risperiDONE) Recalled by Janssen Pharmaceuticals, Inc. Due to Non-Sterility: Janssen is recalling one lot of Risperdal...

Date: September 11, 2013
Company: Janssen 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 Janssen Pharmaceuticals, Inc. directly.

Affected Products

Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11

Quantity: 70,495 kits

Why Was This Recalled?

Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Janssen Pharmaceuticals, Inc.

Janssen Pharmaceuticals, Inc. has 4 total recalls tracked by RecallDetector.

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