Dicloxacillin Sodium Capsules USP — Class III drug recall D-1046-2016
Terminated recall by Sandoz, Inc, reported 2016-06-29, distributed nationwide. Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during
| Recall number | D-1046-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz, Inc, Princeton, NJ, United States |
| Recall initiated | 2016-05-02 |
| Classified | 2016-06-20 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2017-08-17 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00781-2258-01 |
| Lot numbers | EN0389, EP0473, FA4834, FN2602, FW3646 |
| Expiration dates | 2016-08, 2017-02, 2017-11 |
Product
Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
Reason for recall
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during 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-1046-2016. 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.