Lupin Pharmaceuticals recalls 100mg/12.5mg Losartan Potassium and Hydrochlorothiazide Tablets due to AZIDO impurity levels above acceptable limits. Rx-only bottles with specific NDC numbers and lots are affected.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lupin Pharmaceuticals is recalling certain Losartan Potassium and Hydrochlorothiazide Tablets (100 mg/12.5 mg) because they contain AZIDO impurities at levels above acceptable limits. This could pose a health risk if taken by patients.
The recall is due to AZIDO impurities being detected at levels above acceptable limits during manufacturing. While the exact health risk isn't specified, such impurities can potentially cause health issues when taken as medication.
Patients prescribed this medication by a healthcare provider are affected. Those with the specific NDC numbers and production lots listed in the recall are most at risk.
Check for 30-count or 90-count bottles labeled 'Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg' with NDC numbers 68180-216-06 or 68180-216-09. These are prescription-only products manufactured by Lupin Pharmaceuticals.
Identify your bottle's NDC number (68180-216-06 or 68180-216-09) and lot number from the label.
The recall is due to AZIDO impurities being detected at levels above acceptable limits during manufacturing.
Check for 30-count or 90-count bottles with NDC numbers 68180-216-06 or 68180-216-09, which are prescription-only products.
The recall record does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0843-2022 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0843-2022 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.
