FDA Drug recall D-1278-2015
Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma…
- FDA Drug
- Class III
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class III recall of Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma… by Purdue Pharma L P, citing failed dissolution specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1278-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-13 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Purdue Pharma L P |
| Distribution | US |
Product
Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30
Reason
Failed dissolution specifications
Identifiers
| code_info | Lot # 3122833A, Expiry 5/31/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1278-2015%22
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