PrednisoLONE Oral Solution USP — Class III drug recall D-0703-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2017-05-17, distributed nationwide. Failed Stability Specifications
| Recall number | D-0703-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-03-28 |
| Classified | 2017-05-11 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2017-10-24 |
| Distributed | Nationwide (US) |
| Quantity | 49,089 bottles |
| Reason classes | specification failure |
| NDC | 00093-6118-87 |
| Lot numbers | 05/17, 07/17, 12/17, 94358, 94920A, 97083A |
Product
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
Reason for recall
Failed Stability 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-0703-2017. 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.