Ondansetron Tablets USP — Class II drug recall D-0841-2016
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2016-05-18, distributed nationwide. Failed Impurities/Degradation Specifications; 12 month stability time point
| Recall number | D-0841-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2016-03-30 |
| Classified | 2016-05-09 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 50,280 bottles |
| Reason classes | specification failure |
| NDC | 56111-0153-30 |
| Lot numbers | C500691 |
| Expiration dates | 2016-12 |
Product
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Reason for recall
Failed Impurities/Degradation Specifications; 12 month stability time point
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-0841-2016. 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.