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.

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets Recalled by Janssen Pharmaceuticals, Inc. Due to Subpotent Drug

Date: April 29, 2015
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

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.

Quantity: 16,861 cartons/6 blister units (28 tablets) each

Why Was This Recalled?

Subpotent Drug

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.

Related Recalls

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