FDA Drug recall · Reported July 15, 2015
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
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Apotex Inc. recalled Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex… - a moderate-severity action.
Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex… was recalled by Apotex Inc. in July 15, 2015. Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specificati…. Check the official notice for the remedy. Verify recall #D-1212-2015 with the FDA Drug before acting.
The recall
Apotex Inc. issued this moderate-severity FDA Drug recall-Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specificati….
- Moderate
- severity level
- Class II
- classification
- July 15, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1212-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,781 children & baby products recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1212-2015 |
| Date reported | July 15, 2015 |
| Date initiated | May 29, 2015 |
| Recalling firm | Apotex Inc. |
| Firm location | Toronto, N/A |
| Affected scope | 45,708 bottles |
| Distribution | Nationwide, Hawaii and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1212-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Children & Baby Products · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026