Ondansetron HCI API — Class II drug recall D-0164-2017
Terminated recall by Cadila Pharmaceuticals Limited, reported 2016-12-07. Microbial Contamination of Non-Sterile Product
| Recall number | D-0164-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cadila Pharmaceuticals Limited, Ankleshwar, India |
| Recall initiated | 2016-09-09 |
| Classified | 2016-12-01 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2017-06-29 |
| Countries outside the US | RU |
| Quantity | 6 kilograms |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 08/20, 09/20, 150N004, 150N006 |
Product
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Reason for recall
Microbial Contamination of Non-Sterile Product
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-0164-2017. 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.