Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Issues
Sandoz recalls specific lots of 500mg Dicloxacillin Sodium Capsules due to failed impurity specifications. Check your bottle's lot number and expiration date.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Contact the company
What happened, in plain English
Sandoz Inc has recalled specific lots of Dicloxacillin Sodium Capsules USP, 500mg because they failed impurity specifications during testing. The recall affects bottles distributed nationwide with expiration dates ranging from August 2016 to November 2017. Consumers should check their medication's lot number against the affected list. Read more at govinfonow.com/recall/42851-sandoz-recalls-dicloxacillin-sodium-capsules-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42851-sandoz-recalls-dicloxacillin-sodium-capsules-due-to-impurity-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-1046-2016
Cite this page
“Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42851-sandoz-recalls-dicloxacillin-sodium-capsules-due-to-impurity-issues. Based on FDA recall #D-1046-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1046-2016%22&limit=1).
Why it’s dangerous
The recalled capsules contain out-of-specification levels of a known impurity due to degradation or manufacturing issues. While the record does not specify immediate physical injury risks, using medication with failed impurity specifications may compromise its effectiveness or safety profile.
Who’s affected
Individuals who have been prescribed Dicloxacillin Sodium Capsules by Sandoz and possess bottles from the specific lots listed in the recall record. Patients taking this antibiotic are at risk of receiving medication that does not meet quality standards.
How to tell if you have this one
Look for a 100-capsule bottle of Dicloxacillin Sodium Capsules USP, 500mg, Rx Only. Check the label for NDC 0781-2258-01 and one of the following lot numbers: EN0389 (Exp. 8/2016), EP0473 (Exp. 2/2017), FA4834 (Exp. 2/2017), FN2602 (Exp. 2/2017), or FW3646 (Exp. 11/2017). The product is manufactured in Austria by Sandoz Gmbh and distributed by Sandoz Inc in Princeton, NJ.
- Brand
Sandoz- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1045-2016 | Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01; Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017 | 78,606 bottles |
| D-1046-2016 | 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; Lot #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017 | N/A |
What to do — step by step
Check Your Lot Number
Verify if your bottle matches one of the recalled lot numbers: EN0389, EP0473, FA4834, FN2602, or FW3646.
Contact Your Pharmacist
If you have a recalled bottle, contact your pharmacist or healthcare provider for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1046-2016 (May 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1046-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.