Capecitabine tablets USP 500 mg — Class II drug recall D-0732-2016
Terminated recall by Teva North America, reported 2016-03-09, distributed nationwide. Failed Dissolution Specifications: low test results at the 18 month time-point
| Recall number | D-0732-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva North America, Horsham, PA, United States |
| Recall initiated | 2015-12-21 |
| Classified | 2016-03-01 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,895 bottles |
| Reason classes | specification failure |
| NDC | 00093-7473, 00093-7473-06, 00093-7474, 00093-7474-89 |
| Lot numbers | 3A404012V |
| Expiration dates | 2016-04 |
Product
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
Reason for recall
Failed Dissolution Specifications: low test results at the 18 month 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-0732-2016. 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.