Data Foundry

Drug recalls 2016

Intermezzo — Class III drug recall D-0810-2016

Terminated recall by Purdue Pharma L.P., reported 2016-04-13, distributed in FL, LA, MI, MS, NC, NJ, OH, SC. Failed Dissolution Specifications

Recall numberD-0810-2016
Product typeDrug
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPurdue Pharma L.P., Stamford, CT, United States
Recall initiated2016-03-31
Classified2016-04-04
Reported by FDA2016-04-13
Terminated2017-04-12
DistributedFL, LA, MI, MS, NC, NJ, OH, SC
Quantity2,172 cartons
Reason classesspecification failure
NDC59011-0256-30
Lot numbers3126431B
Expiration dates2017-09-30

Product

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.

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-0810-2016. 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.