FDA Drug recall D-1046-2016
Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. ,…
- FDA Drug
- Class III
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class III recall of Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. ,… by Sandoz, citing failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1046-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-02 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
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
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Identifiers
| code_info | Lot #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1046-2016%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.