Valeant Recalls Diazepam Rectal Gel Due to Labeling Errors
Valeant recalls 306 cartons of Diazepam Rectal Gel, 2.5 mg twin packs distributed nationwide due to missing or incorrect lot and expiration dates on outer cartons.
Lower-risk recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Contact the company
What happened, in plain English
Valeant Pharmaceuticals North America LLC is recalling Diazepam Rectal Gel, 2.5 mg, TWIN PACK because the outer carton may lack a lot number or expiration date. The product was distributed nationwide in the USA. This recall affects 306 cartons of the medication. Read more at govinfonow.com/recall/40379-valeant-recalls-diazepam-rectal-gel-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/40379-valeant-recalls-diazepam-rectal-gel-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-1041-2018
Cite this page
“Valeant Recalls Diazepam Rectal Gel Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40379-valeant-recalls-diazepam-rectal-gel-due-to-labeling-errors. Based on FDA recall #D-1041-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1041-2018%22&limit=1).
Why it’s dangerous
The hazard is a labeling error where the outer carton does not display a lot number or expiration date. This makes it difficult to verify the product's identity and freshness, which could lead to using expired medication or confusion during an emergency.
Who’s affected
Consumers who purchased Diazepam Rectal Gel, 2.5 mg, TWIN PACK from pharmacies or healthcare providers across the United States. Patients relying on this specific lot for seizure management are most affected by the labeling issue.
How to tell if you have this one
Check your Diazepam Rectal Gel, 2.5 mg, TWIN PACK for NDC 68682-650-20. Look at the outer carton for Lot # NBBN and Exp 02/22. Verify if the lot number or expiration date is missing or incorrect on the packaging.
- Brand
Valeant Pharmaceuticals- Category
Drug
What to do — step by step
Check your product
Inspect the outer carton of your Diazepam Rectal Gel, 2.5 mg, TWIN PACK for NDC 68682-650-20 and Lot # NBBN.
Contact your pharmacy
Reach out to the pharmacy where you purchased the medication to report the labeling issue and discuss next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 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
What is the specific product being recalled?
The recall involves Diazepam Rectal Gel, 2.5 mg, TWIN PACK containing two pre-filled, unit-dose, rectal delivery systems.
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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-1041-2018 (July 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1041-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.