Purdue Pharma Recalls Intermezzo 3.5 mg Due to Dissolution Failure
Purdue Pharma recalls Intermezzo sublingual tablets due to failed dissolution specifications. Check lot numbers and expiry dates for affected units.
Use caution until it’s fixed
Failed dissolution specifications
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What happened, in plain English
Purdue Pharma L.P. is recalling Intermezzo (zolpidem tartrate) sublingual tablets, 3.5 mg strength. The recall is necessary because the product failed dissolution specifications, which may affect how the medication works. This specific recall involves 6,264 cartons distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/44098-purdue-pharma-l-p-recalls-intermezzo-zolpidem-tartrate-sublingual-tablet.
Source Summary by GovInfoNow · govinfonow.com/recall/44098-purdue-pharma-l-p-recalls-intermezzo-zolpidem-tartrate-sublingual-tablet · Updated October 12, 2026 · FDA enforcement record: FDA #D-1278-2015
Cite this page
“Purdue Pharma Recalls Intermezzo 3.5 mg Due to Dissolution Failure.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44098-purdue-pharma-l-p-recalls-intermezzo-zolpidem-tartrate-sublingual-tablet. Based on FDA recall #D-1278-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1278-2015%22&limit=1).
Why it’s dangerous
The tablets failed to meet dissolution specifications, meaning the drug may not release properly in the body. This could result in the medication not working as intended for its prescribed use.
Who’s affected
Patients who have been prescribed Intermezzo sublingual tablets, specifically those with NDC 59011-265-30. The affected units are from Lot # 3122833A with an expiry date of 5/31/16.
How to tell if you have this one
Look for Intermezzo sublingual tablets, 3.5 mg, packaged as 1 tablet per pouch with 30 pouches per carton. Check for NDC 59011-265-30, Lot # 3122833A, and an expiry date of 5/31/16.
- Brand
Purdue Pharma- Category
Drug
What to do — step by step
Check your medication
Verify if you have Intermezzo sublingual tablets with NDC 59011-265-30, Lot # 3122833A, and expiry 5/31/16.
Contact your pharmacist
Speak with your healthcare provider or pharmacist to discuss the recall and potential replacement options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 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-1278-2015 (July 13, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1278-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.