The Recall Desk
ModerateFDA (Drugs)·D-1213-2015·Announced 2015-07-15

Apotex Recalls Losartan Potassium Tablets for Blend Uniformity Failure

Apotex Inc. is recalling Losartan potassium tablets 100 mg because they may not meet blend uniformity specifications. The recall covers 23,178 bottles distributed nationwide, in Hawaii, and Puerto Rico.

What this means for you

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 II, and the hazard is a potential failure in blend uniformity without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Apotex Inc. is recalling Losartan potassium tablets USP, 100 mg, 90-count bottles. The recall is due to a failure in content uniformity specifications, specifically that the product may not meet the limit for blend uniformity. The affected product is manufactured for Apotex Inc. by Apotex Research Private Limited in India.

The recall involves 23,178 bottles of the medication. The affected lots are KT3819 and KT3821, both with an expiration date of 11/2015. The product was distributed nationwide, as well as in Hawaii and Puerto Rico.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9
Manufacturer
Apotex Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
23,178

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 (3)

  • Lot #: KT3819
  • Exp 11/2015
  • Lot #: KT3821

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Apotex 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 4 products in this recall →

Related recalls

Same manufacturer · Apotex Inc.

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Same hazard · blend uniformity

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