Janssen Recalls Ortho-Novum 7/7/7 Tablets Due to Incorrect Dispenser Instructions
Janssen Pharmaceuticals is recalling Ortho-Novum 7/7/7 tablets because the packaging included instructions for the wrong type of pill dispenser.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a minor labeling error involving incorrect instructions for a specific dispenser type, which fits the criteria for a moderate severity recall.
Plain-English summary
Janssen Pharmaceuticals, Inc. is recalling specific lots of Ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol) tablets. The recall is due to a labeling error where the instructions provided for the Veridate tablet dispenser incorrectly described the use of a Dialpak dispenser.
The affected products are packaged in Veridate Tablet Dispensers and Refill pouches. The recall covers Lot 18CM120 (expiration 03/2020) and Lot 18BM110 (expiration 03/2020). These products were distributed nationwide in the USA.
Consumers with these specific lots should stop using the product and contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- 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…
- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: a) 18CM120
- Exp 03/2020
- b) 18BM110
- Exp. 03/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Janssen Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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