QUETIAPINE Fumarate Tablets 25mg 100 Tablets — Class II drug recall D-802-2013
Terminated recall by American Health Packaging, reported 2013-07-24, distributed nationwide. Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, a
| Recall number | D-802-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2012-10-10 |
| Classified | 2013-07-15 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2013-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 19,060 blister |
| Reason classes | specification failure |
| NDC | 68084-0530-01 |
| Lot numbers | 03/14, 122600 |
Product
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Reason for recall
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
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-802-2013. 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.