Data Foundry

Drug recalls 2015

Intermezzo — Class III drug recall D-1278-2015

Terminated recall by Purdue Pharma L.P., reported 2015-07-29, distributed nationwide. Failed dissolution specifications

Recall numberD-1278-2015
Product typeDrug
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPurdue Pharma L.P., Stamford, CT, United States
Recall initiated2015-07-13
Classified2015-07-21
Reported by FDA2015-07-29
Terminated2017-05-15
DistributedNationwide (US)
Reason classesspecification failure
NDC59011-0265-30
Lot numbers3122833A
Expiration dates2016-05-31

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 for recall

Failed dissolution specifications

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1278-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.