Direct Rx recalls Losartan/HCTZ 100/12.5mg tablets with AZIDO impurities above safe levels. Affected lots from 2021-2023. Stop using immediately.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Direct Rx is recalling Losartan/HCTZ 100/12.5mg tablets due to unsafe AZIDO impurities. These impurities could cause serious health risks if taken. Affected products have specific lot numbers and expiration dates.
The medication contains AZIDO impurities at levels above what's safe. These impurities can cause serious health issues when taken, including potential kidney damage or other adverse effects.
People who purchased the recalled Losartan/HCTZ 100/12.5mg tablets from Direct Rx. Those with hypertension or kidney conditions are at higher risk.
Check for lot numbers on the bottle: 11MY2103, 05JA2106, 20MY2115, 22JU2118, 29JY2113, or 13SE2113. The products were sold between 2021 and 2023 with specific expiration dates.
Discard all recalled Losartan/HCTZ 100/12.5mg tablets if you have them.
The recall record states AZIDO impurities were observed at levels above acceptable limits, but does not specify the exact type or quantity.
Affected lots include 11MY2103, 05JA2106, 20MY2115, 22JU2118, 29JY2113, and 13SE2113.
Check the lot number on the bottle. The affected products have specific lot numbers and expiration dates listed in the recall notice.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0971-2022 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0971-2022 from Direct Rx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
