FDA Drug recall D-0732-2016
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries…
- FDA Drug
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries… by Teva North America, citing failed Dissolution Specifications: low test results at the 18 month time-point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0732-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-21 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva North America |
| Distribution | US |
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
Failed Dissolution Specifications: low test results at the 18 month time-point
Identifiers
| ndc | 0093-7473-06 |
|---|---|
| ndc | 0093-7474-89 |
| code_info | Lot # 3A404012V, Exp. 4/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0732-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.