Losartan potassium tablets USP — Class II drug recall D-1214-2015
Terminated recall by Apotex Inc., reported 2015-07-15, distributed nationwide. Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specificatio
| Recall number | D-1214-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, N/A, Canada |
| Recall initiated | 2015-05-29 |
| Classified | 2015-07-07 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2017-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 23,076 bottles |
| NDC | 60505-3161-09 |
| Lot numbers | KN1449 |
| Expiration dates | 2015-06 |
Product
Losartan potassium tablets USP, 50 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 60505-3161-9
Reason for recall
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1214-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.