Lupin Pharmaceuticals recalls 30-count and 90-count Losartan Potassium and Hydrochlorothiazide Tablets (100 mg/25 mg) with AZIDO impurities above acceptable limits. Rx only, manufactured in India with US distribution.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide Tablets (100 mg/25 mg) because they contain AZIDO impurities at levels above acceptable limits. This could pose a health risk if the impurities are ingested.
The recall is due to AZIDO impurities found in the medication at levels above acceptable limits. While the exact health risk isn't specified, impurities like AZIDO can be harmful if ingested in significant amounts.
People who have purchased the recalled Losartan Potassium and Hydrochlorothiazide Tablets (100 mg/25 mg) from pharmacies or doctors. Those with hypertension or heart conditions requiring this medication are most at risk.
Check for 30-count or 90-count bottles labeled 'Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg' with NDC numbers 68180-217-06 or 68180-217-09. These were manufactured by Lupin Pharmaceuticals in India and distributed in the US.
Verify the product's NDC number and batch number to confirm if it's part of the recall.
The recall states that AZIDO impurities were found above acceptable limits, but the official notice does not specify if the medication is safe to take.
Check the NDC number on the product label. Recalled items have NDC numbers 68180-217-06 or 68180-217-09.
The official recall notice does not specify a remedy, so contact Lupin Pharmaceuticals for further instructions.
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-0842-2022 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0842-2022 from Lupin. 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.
