Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets Recalled by Janssen Pharmaceuticals, Inc. Due to Labeling: Incorrect Instructions; Instructions included for use with...
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-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.
Quantity: a) 3,956 cartons; b) 1 carton
Why Was This Recalled?
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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