Zolpidem Tartrate Tablets 5 mg — Class II drug recall D-856-2013
Terminated recall by American Health Packaging, reported 2013-08-14, distributed nationwide. Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase t
| Recall number | D-856-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2013-05-21 |
| Classified | 2013-08-08 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Quantity | 48.23 cartons |
| NDC | 68084-0225-01 |
| Lot numbers | 114215, 114216, 114217, 120087, 120295, 121573, 123572, 123983, 130071, 2/15, 6/14, 7/13, 9/13, 9/14 |
Product
Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
Reason for recall
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
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-856-2013. 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.