Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Test Failure
Sandoz, Inc. is recalling specific lots of Dicloxacillin Sodium Capsules, 500mg, because testing revealed an out-of-specification result for a known impurity.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a quality control failure (impurity) without reported illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Sandoz, Inc. is recalling Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottles. The product is manufactured in Austria by Sandoz GmbH and distributed by Sandoz Inc. in Princeton, NJ. The recall affects specific lots with expiration dates ranging from August 2016 to November 2017.
The recall was initiated because testing resulted in an out-of-specification finding for a known impurity. This indicates that the product failed to meet established impurity or degradation specifications during quality control testing.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been prescribed this medication.
The recalled product
- 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
- Manufacturer
- Sandoz, Inc
- Category
- Drug — Antibiotic
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 (8)
- Lot #: EN0389
- EP0473
- Exp. 8/2016
- FA4834
- FN2602
- Exp. 2/2017
- FW3646
- Exp.11/2017
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.
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