Lupin Pharmaceuticals recalls 50mg/12.5mg Losartan Potassium and Hydrochlorothiazide Tablets due to AZIDO impurity levels above acceptable limits. Rx-only bottles with specific NDC numbers and production dates are affected.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lupin Pharmaceuticals is recalling certain Losartan Potassium and Hydrochlorothiazide Tablets (50 mg/12.5 mg) because they contain AZIDO impurities at levels above what's allowed. This could pose a health risk if taken as prescribed.
The recall is due to AZIDO impurities being found in the medication at levels above acceptable limits. While the exact health risk isn't specified in the notice, such impurities can potentially cause health issues when taken as medication.
People who have the recalled 30-count or 90-count bottles with the listed NDC numbers and production dates should check their medication. Those taking blood pressure medication may be at risk if they use the affected tablets.
Check for 30-count or 90-count bottles labeled 'Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg' with NDC numbers 68180-215-06 or 68180-215-09. The affected lots have specific production dates listed in the recall notice.
Look for the NDC numbers 68180-215-06 or 68180-215-09 on the bottle label and verify the production date against the list provided in the recall.
The recall is due to AZIDO impurities being found at levels above acceptable limits during manufacturing.
The official notice does not specify a stop-use instruction, only that the affected lots contain impurities above acceptable levels.
Check the NDC number on the bottle (68180-215-06 or 68180-215-09) and compare the production date against the list provided in the recall notice.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0841-2022 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0841-2022 from Lupin Pharmaceuticals. 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.
