Valeant Recalls Secobarbital Sodium Due to Missing Anaphylaxis Warning
Valeant recalls 958 bottles of Secobarbital Sodium capsules because the package insert is missing a warning about anaphylaxis. Check your lot number.
Use caution until it’s fixed
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Contact the company
What happened, in plain English
Valeant Pharmaceuticals North America LLC has recalled one lot of SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles. The recall is necessary because the package insert is missing a warning regarding anaphylaxis. This means patients may not be aware of this serious allergic reaction risk when taking the medication. Read more at govinfonow.com/recall/42590-valeant-recalls-secobarbital-sodium-due-to-missing-anaphylaxis-warning.
Source Summary by GovInfoNow · govinfonow.com/recall/42590-valeant-recalls-secobarbital-sodium-due-to-missing-anaphylaxis-warning · Updated October 9, 2026 · FDA enforcement record: FDA #D-1059-2016
Cite this page
“Valeant Recalls Secobarbital Sodium Due to Missing Anaphylaxis Warning.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42590-valeant-recalls-secobarbital-sodium-due-to-missing-anaphylaxis-warning. Based on FDA recall #D-1059-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1059-2016%22&limit=1).
Why it’s dangerous
The hazard is a labeling deficiency where the package insert fails to include a warning about anaphylaxis. Without this information, patients and healthcare providers might not recognize or take appropriate precautions for this serious allergic reaction risk associated with the drug.
Who’s affected
Patients who have been prescribed SECONAL SODIUM Capsules, USP, 100 mg, 100 Ct. Bottles distributed by Valeant Pharmaceuticals North America LLC. The specific affected lot is 2555979 with an expiry date of 09/2016.
How to tell if you have this one
Check if you have SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Look for NDC: 0187-4220-10 and Lot #: 2555979 with an expiry date of 09/2016. These were distributed nationwide in the US.
- Brand
Valeant- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches NDC: 0187-4220-10 and Lot #: 2555979 with an expiry of 09/2016.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for guidance on what to do next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US 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 12 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.
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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-1059-2016 (June 10, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1059-2016 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.