Risedronate Sodium Delayed-release Tablets — Class III drug recall D-0511-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2017-03-15, distributed nationwide. Failed Dissolution Specifications: low out of specification dissolution results found during stability testing
| Recall number | D-0511-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-02-17 |
| Classified | 2017-03-03 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2018-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 25,916 cartons |
| Reason classes | specification failure |
| NDC | 00093-5509-19, 00093-5509-44 |
| Lot numbers | 06/17, 34025762A |
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: low out of specification dissolution results found during stability testing.
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-0511-2017. 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.