Purdue Recalls Intermezzo Tablets Due to Dissolution Failure
Purdue Pharma recalls specific lots of Intermezzo (zolpidem tartrate) 1.75 mg sublingual tablets due to failed dissolution specifications.
Use caution until it’s fixed
Failed Dissolution Specifications
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What happened, in plain English
Purdue Pharma L.P. has recalled specific lots of Intermezzo (zolpidem tartrate) sublingual tablets, 1.75 mg, because they failed dissolution specifications. This means the medication may not release or work as intended. The recall affects 2,172 cartons distributed in several U.S. states. Read more at govinfonow.com/recall/43021-purdue-recalls-intermezzo-tablets-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/43021-purdue-recalls-intermezzo-tablets-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0810-2016
Cite this page
“Purdue Recalls Intermezzo Tablets Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43021-purdue-recalls-intermezzo-tablets-due-to-dissolution-failure. Based on FDA recall #D-0810-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0810-2016%22&limit=1).
Why it’s dangerous
The tablets failed to meet dissolution specifications, which is a quality control standard ensuring the drug releases properly in the body. If the tablet does not dissolve correctly, the patient may not receive the full dose of zolpidem tartrate, potentially leading to treatment failure for insomnia.
Who’s affected
Patients who have been prescribed Intermezzo for insomnia and purchased the affected cartons between the manufacturing date and the recall announcement. Individuals relying on this specific dosage for sleep may find it ineffective.
How to tell if you have this one
Check your medication carton for NDC 59011-256-30 and Lot # 3126431B with an expiry date of 09/30/17. The product is a CIV, Rx-only, 30-count carton of Intermezzo sublingual tablets distributed by Purdue Pharma L.P.
- Brand
Purdue Pharma- Category
Drug
What to do — step by step
Check your medication
Verify if your Intermezzo carton matches NDC 59011-256-30 and Lot # 3126431B with an expiry of 09/30/17.
Contact your pharmacist
If you have the affected product, speak with your pharmacist or healthcare provider about replacing it or adjusting your treatment plan.
Where it went and when
Where it was distributed
Distributed in 8 states.
FDA distribution: “U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Louisiana, Michigan, Mississippi, New Jersey, North Carolina, Ohio, South Carolina.
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.
Questions people ask
How many cartons are being recalled?
A total of 2,172 cartons 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-0810-2016 (March 31, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0810-2016 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.