# FDA recall D-1212-2015

> **Apotex Inc.** · Class II · drug recall initiated 2015-05-29.

## 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

## Reason for recall

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

## Distribution

Nationwide, Hawaii and Puerto Rico

## Key facts

- **Recall number:** D-1212-2015
- **Recalling firm:** Apotex Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-05-29
- **Report date:** 2015-07-15
- **Termination date:** 2017-03-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toronto, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1212-2015

## Citation

> AI Analytics. FDA recall D-1212-2015. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1212-2015. Source: US FDA. Licensed CC0.

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