Lodrane D Recall: Mislabeling Hazard Explained
Valeant recalls Lodrane D capsules due to cartons being mislabeled with the wrong active ingredient. Check your lot numbers and expiration date.
Use caution until it’s fixed
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Contact the company
What happened, in plain English
Valeant Pharmaceuticals is recalling 3,827 bottles of Lodrane D capsules because the outer cartons were incorrectly labeled. The packaging listed phenylephrine as an active ingredient instead of the correct pseudoephedrine. This labeling error could lead to confusion regarding the medication's contents. Read more at govinfonow.com/recall/42603-lodrane-d-recall-mislabeling-hazard-explained.
Source Summary by GovInfoNow · govinfonow.com/recall/42603-lodrane-d-recall-mislabeling-hazard-explained · Updated October 9, 2026 · FDA enforcement record: FDA #D-1032-2016
Cite this page
“Lodrane D Recall: Mislabeling Hazard Explained.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42603-lodrane-d-recall-mislabeling-hazard-explained. Based on FDA recall #D-1032-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1032-2016%22&limit=1).
Why it’s dangerous
The hazard is that the carton face and top display phenylephrine instead of pseudoephedrine. While the capsules inside may be correct, the mislabeling creates a significant risk of medication error or confusion for users who rely on accurate ingredient information for their health conditions.
Who’s affected
Consumers who purchased Lodrane D capsules distributed by Valeant Pharmaceuticals North America LLC nationwide are affected. Individuals relying on this specific decongestant formulation are at risk of receiving a product with incorrect labeling information.
How to tell if you have this one
Look for 60-count bottles of Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) with UPC 0 00950 86006 8. Check the cartons for lot numbers P0230-022R or P0230-023R with an expiration date of 06/17.
- Brand
Lodrane D- Product
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by- Category
Drug
What to do — step by step
Check Your Product Details
Verify if your bottle has the correct UPC and matches one of the recalled lot numbers with the specified expiration date.
Contact the Manufacturer
Since no specific remedy is stated in the record, contact Valeant Pharmaceuticals North America LLC for further instructions on how to proceed.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many bottles are being recalled?
A total of 3,827 bottles are included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1032-2016 (May 23, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1032-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.