The Recall Desk
ModerateFDA (Drugs)·D-1212-2015·Announced 2015-07-15

Apotex Recalls Losartan Potassium Tablets Due to Uniformity Issues

Apotex Inc. is recalling Losartan potassium tablets 25 mg because they may not meet blend uniformity specifications. The recall covers 45,708 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, which typically corresponds to a moderate severity level involving temporary or reversible health consequences, such as potential dosage variability due to blend uniformity issues.

Plain-English summary

Apotex Inc. is recalling Losartan potassium tablets USP, 25 mg, 90-count bottles (NDC 60505-3160-9) because the product may not meet the limit for blend uniformity specification. The recall involves 45,708 bottles with Lot # KP4726 and an expiration date of 9/2015.

The affected product was distributed nationwide, in Hawaii, and in Puerto Rico. The tablets are prescription-only and were manufactured for Apotex Inc. by Apotex Research Private Limited in India.

Consumers with this medication should contact their healthcare provider or pharmacist for guidance on alternative treatment or replacement. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Losartan potassium tablets USP, 25 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 60505-3160-9
Manufacturer
Apotex Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
45,708

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 (2)

  • Lot #: KP4726
  • Exp date 9/2015

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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