Risedronate Sodium Delayed-release Tablets — Class III drug recall D-0431-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2017-01-25, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0431-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2016-12-01 |
| Classified | 2017-01-13 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 6,800 cartons |
| Reason classes | specification failure |
| NDC | 00093-5509-19, 00093-5509-44 |
| Lot numbers | 10/17, 34027040A |
Product
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Reason for recall
Failed Dissolution Specifications
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-0431-2017. 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.