Dr — Class II drug recall D-059-2013
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2012-11-28, distributed nationwide. Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time poin
| Recall number | D-059-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Bridgewater, NJ, United States |
| Recall initiated | 2012-09-27 |
| Classified | 2012-11-20 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,512 bottles |
| Reason classes | specification failure |
| NDC | 55111-0249-05 |
| Lot numbers | 03/14, C203090 |
Product
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Reason for recall
Failed USP 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-059-2013. 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.