CLASS III Drug recall · Reported 29 Jun 2016 · FDA Enforcement Report
Dicloxacillin Sodium Capsules, USP 250mg recalled by Sandoz
Sandoz is recalling Dicloxacillin Sodium Capsules, USP 250mg, distributed nationwide in the US. The recall was initiated on 2 May 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1045-2016
- FDA event ID
- 74068
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 May 2016
- FDA classified
- 20 Jun 2016
- Reported
- 29 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 2 May 2016 | Recall initiated by company | |
| 20 Jun 2016 | Classified by FDA | +49 days |
| 29 Jun 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Which lots are affected?
Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 74068This product is part of a recall event; the main page for the event is Dicloxacillin Sodium Capsules USP, 500mg recalled by Sandoz.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Dicloxacillin Sodium Capsules USP, 500mg recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |
More recalls from Sandoz
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
Other Dicloxacillin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dicloxacillin Sodium Capsules USP, 500mg recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |