The Recall Desk
LowFDA (Drugs)·D-1045-2016·Announced 2016-06-29

Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Testing Failures

Sandoz, Inc. is recalling Dicloxacillin Sodium Capsules because testing revealed out-of-specification results for a known impurity.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences, aligning with the 'Low' severity criterion for documentation or minor specification issues.

Plain-English summary

Sandoz, Inc. is recalling Dicloxacillin Sodium Capsules, USP 250mg, 100 Capsule Bottle (NDC 0781-2248-01). The product was manufactured in Austria by Sandoz GmbH and distributed nationwide by Sandoz, Inc. in Princeton, NJ. The recall involves 78,606 bottles.

The recall was initiated due to failed impurities and degradation specifications. Specifically, testing obtained an out-of-specification result for a known impurity. The affected lots are EN3846 (Exp 08/2016), FA4809 (Exp 2/2017), and FW3654 (Exp 11/2017).

The FDA has classified this as a Class III recall. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
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
Manufacturer
Sandoz, Inc
Category
Drug — Antibiotic
Hazard
Affected units
78,606

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #s: EN3846
  • Exp 08/2016
  • FA4809
  • Exp 2/2017
  • FW3654
  • Exp11/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Sandoz, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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