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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 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…
- 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
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.
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