CLASS III Drug recall · Reported 13 Apr 2016 · FDA Enforcement Report
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV recalled
Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, distributed in 8 states. The recall was initiated on 31 Mar 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0810-2016
- FDA event ID
- 73709
- Recalling firm
- Purdue Pharma, Stamford, CT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Mar 2016
- FDA classified
- 4 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 31 Mar 2016 | Recall initiated by company | |
| 4 Apr 2016 | Classified by FDA | +4 days |
| 13 Apr 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
Where it was distributed
U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.
FloridaLouisianaMichiganMississippiNorth CarolinaNew JerseyOhioSouth Carolina
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: 3126431B, Expiry: 09/30/17
Where was it sold?
U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Purdue Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Betadine Solution Swabstick Povidone-Iodine Solution recalledBetadine | Purdue Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Intermezzo (zolpidem tartrate) recalled by Purdue Pharma | Purdue Pharma | Potency & Assay | Nationwide |