Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported November 14, 2018
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
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Janssen Pharmaceuticals, Inc. recalled Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.0… - a moderate-severity action.
Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.0… was recalled by Janssen Pharmaceuticals, Inc. in November 14, 2018. Reason: Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instru…. Check the official notice for the remedy. Verify recall #D-0218-2019 with the FDA Drug before acting.
The recall
Janssen Pharmaceuticals, Inc. issued this moderate-severity FDA Drug recall-Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instru….
- Moderate
- severity level
- Class II
- classification
- November 14, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0218-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0218-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on October 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Janssen Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Titusville, NJ. Federal records list the affected scope as a) 3,956 cartons; b) 1 carton.
The documented reason for this recall is: Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
a) 3,956 cartons; b) 1 carton
Related Recalls
6
5 from same agency
Product description
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.
Reason for recall
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0218-2019 |
| Date reported | November 14, 2018 |
| Date initiated | October 23, 2018 |
| Recalling firm | Janssen Pharmaceuticals, Inc. |
| Firm location | Titusville, NJ |
| Affected scope | a) 3,956 cartons; b) 1 carton |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0218-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Janssen Pharmaceuticals, Inc.. Units affected: a) 3,956 cartons; b) 1 carton.
Why was this product recalled? ▼
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 14, 2018. Severity: Moderate. Recall number: D-0218-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0218-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 14, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.